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- ||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P4 trial: A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn (clinicaltrials.gov) - Jan 27, 2023
P4, N=338, Not yet recruiting, Sponsor: HK inno.N Corporation
- ||||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion: Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis (clinicaltrials.gov) - Jan 27, 2023
P3, N=351, Completed, Sponsor: HK inno.N Corporation
Unknown status --> Completed
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion date, Trial primary completion date: PROTECT-HBR: Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy (clinicaltrials.gov) - Dec 12, 2022
P4, N=2600, Recruiting, Sponsor: Duk-Woo Park, MD
Unknown status --> Completed Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P4 trial: A RCT of the Efficacy of Tegoprazan 50mg QD in the Treatment of Helicobacter Pylori Infection ( TATH-1 ) (clinicaltrials.gov) - Dec 12, 2022
P4, N=100, Active, not recruiting, Sponsor: Zhang Xiaofeng,MD
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela, Takecab (vonoprazan) / Takeda, Phathom Pharma
New trial: The Effect of Time Intervals for Rescue Treatment on Eradication Effect of Helicobacter Pylori Infection (clinicaltrials.gov) - Nov 17, 2022
P=N/A, N=626, Not yet recruiting, Sponsor: Shandong University
- |||||||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P3 trial: A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis (clinicaltrials.gov) - Oct 20, 2022
P3, N=1250, Recruiting, Sponsor: Braintree Laboratories
- |||||||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P3 trial: A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease (clinicaltrials.gov) - Oct 20, 2022
P3, N=633, Recruiting, Sponsor: Braintree Laboratories
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P4 trial: The Efficacy of 10-day or 14-day Course of Bismuth-containing Quadruple Therapy:A Randomized Clinical Trial (clinicaltrials.gov) - Oct 19, 2022
P4, N=398, Not yet recruiting, Sponsor: Shandong University
- |||||||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P3 trial: Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori (clinicaltrials.gov) - Oct 13, 2022
P3, N=560, Not yet recruiting, Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
- |||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion: Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease (clinicaltrials.gov) - Jul 29, 2022
P4, N=218, Completed, Sponsor: HK inno.N Corporation
Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Sep 2025 Recruiting --> Completed
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P4 trial: 14-day Double Therapy Versus Bismuth Quadruple Therapy in First-line Treatment of Helicobacter Pylori Infection (clinicaltrials.gov) - Jun 30, 2022
P4, N=258, Not yet recruiting, Sponsor: Shandong University
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela, IN-C005 / Korea Kolmar
Trial completion, Trial completion date: Evaluation of the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 and IN-A001 in Healthy Caucasians (clinicaltrials.gov) - May 15, 2022
P1, N=20, Completed, Sponsor: HK inno.N Corporation
Recruiting --> Completed Not yet recruiting --> Completed | Trial completion date: May 2022 --> Nov 2021
- |||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment open: Efficacy and Safety of LXI-15028 Comparing With Lansoprazole in the Treatment of Duodenal Ulcer (clinicaltrials.gov) - May 6, 2022
P3, N=400, Recruiting, Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Not yet recruiting --> Completed | Trial completion date: May 2022 --> Nov 2021 Not yet recruiting --> Recruiting
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P1 trial: A Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers (clinicaltrials.gov) - Apr 28, 2022
P1, N=12, Not yet recruiting, Sponsor: HK inno.N Corporation
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion date, Trial primary completion date: PROTECT-HBR: Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy (clinicaltrials.gov) - Mar 8, 2022
P4, N=3000, Recruiting, Sponsor: Duk-Woo Park, MD
Not yet recruiting --> Recruiting Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Sep 2024
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment closed: Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection (clinicaltrials.gov) - Feb 10, 2022
P=N/A, N=217, Active, not recruiting, Sponsor: Incheon St.Mary's Hospital
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Sep 2024 Not yet recruiting --> Active, not recruiting
- K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion: Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance (clinicaltrials.gov) - Dec 17, 2021
P4, N=46, Completed, Sponsor: HK inno.N Corporation
Not yet recruiting --> Active, not recruiting Recruiting --> Completed
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion: Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers (clinicaltrials.gov) - Sep 26, 2021
P1, N=19, Completed, Sponsor: Seoul National University Hospital
Recruiting --> Completed Recruiting --> Completed
- |||||||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P3 trial: Efficacy and Safety of LXI-15028 Comparing With Lansoprazole in the Treatment of Duodenal Ulcer (clinicaltrials.gov) - Aug 17, 2021
P3, N=400, Not yet recruiting, Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela, IN-C005 / Korea Kolmar
New P1 trial: Evaluation of the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 and IN-A001 in Healthy Caucasians (clinicaltrials.gov) - Aug 12, 2021
P1, N=20, Not yet recruiting, Sponsor: HK inno.N Corporation
- K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment open, Trial completion date, Trial primary completion date: Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance (clinicaltrials.gov) - Jul 8, 2021
P4, N=46, Recruiting, Sponsor: HK inno.N Corporation
Recruiting --> Completed Not yet recruiting --> Recruiting | Trial completion date: Dec 2020 --> Nov 2021 | Trial primary completion date: Nov 2020 --> Nov 2021
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment open: PROTECT-HBR: Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy (clinicaltrials.gov) - May 13, 2021
P4, N=3000, Recruiting, Sponsor: Duk-Woo Park, MD
Not yet recruiting --> Recruiting | Trial completion date: Dec 2020 --> Nov 2021 | Trial primary completion date: Nov 2020 --> Nov 2021 Not yet recruiting --> Recruiting
- ||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion, Trial completion date: Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT (clinicaltrials.gov) - May 11, 2021
P3, N=102, Completed, Sponsor: HK inno.N Corporation
Not yet recruiting --> Recruiting Recruiting --> Completed | Trial completion date: Aug 2021 --> Jan 2021
- |||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment open: Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs (clinicaltrials.gov) - May 10, 2021
P3, N=390, Recruiting, Sponsor: HK inno.N Corporation
Recruiting --> Completed | Trial completion date: Aug 2021 --> Jan 2021 Not yet recruiting --> Recruiting
- |||||||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P3 trial: Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs (clinicaltrials.gov) - Apr 12, 2021
P3, N=390, Not yet recruiting, Sponsor: HK inno.N Corporation
- || IN-C004 / Korea Kolmar
Trial completion: Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers (clinicaltrials.gov) - Mar 28, 2021
P1, N=48, Completed, Sponsor: HK inno.N Corporation
Not yet recruiting --> Recruiting Recruiting --> Completed
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment open: Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers (clinicaltrials.gov) - Mar 18, 2021
P1, N=16, Recruiting, Sponsor: Seoul National University Hospital
Recruiting --> Completed Not yet recruiting --> Recruiting
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial initiation date: PROTECT-HBR: Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy (clinicaltrials.gov) - Feb 22, 2021
P4, N=3000, Not yet recruiting, Sponsor: Duk-Woo Park, MD
Not yet recruiting --> Recruiting Initiation date: Dec 2020 --> Mar 2021
- || IN-C004 / Korea Kolmar
Enrollment open: Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers (clinicaltrials.gov) - Jan 28, 2021
P1, N=48, Recruiting, Sponsor: HK inno.N Corporation
Initiation date: Dec 2020 --> Mar 2021 Not yet recruiting --> Recruiting
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: A Study to Explore Pharmacokinetics/Pharmacodynamics and Safety of Tegoprazan BID Dosing in Healthy Subjects (clinicaltrials.gov) - Dec 27, 2020
P1, N=40, Recruiting, Sponsor: HK inno.N Corporation
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | N=64 --> 40 | Trial completion date: Sep 2021 --> Jun 2021 | Trial primary completion date: Jun 2021 --> Mar 2021
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
New trial: Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection (clinicaltrials.gov) - Dec 19, 2020
P=N/A, N=216, Not yet recruiting, Sponsor: Incheon St.Mary's Hospital
- || IN-C004 / Korea Kolmar
New P1 trial: Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers (clinicaltrials.gov) - Dec 3, 2020
P1, N=48, Not yet recruiting, Sponsor: HK inno.N Corporation
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion, Trial primary completion date: Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers (clinicaltrials.gov) - Nov 30, 2020
P1, N=19, Completed, Sponsor: HK inno.N Corporation
Not yet recruiting --> Recruiting | N=64 --> 40 | Trial completion date: Sep 2021 --> Jun 2021 | Trial primary completion date: Jun 2021 --> Mar 2021 Recruiting --> Completed | Trial primary completion date: Apr 2020 --> Jul 2020
- ||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P1 trial: Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers (clinicaltrials.gov) - Nov 22, 2020
P1, N=60, Completed, Sponsor: HK inno.N Corporation
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment open: A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls (clinicaltrials.gov) - Nov 9, 2020
P1, N=28, Recruiting, Sponsor: HK inno.N Corporation
Recruiting --> Completed | Trial primary completion date: Apr 2020 --> Jul 2020 Not yet recruiting --> Recruiting
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial initiation date: PROTECT-HBR: Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy (clinicaltrials.gov) - Oct 28, 2020
P4, N=2500, Not yet recruiting, Sponsor: Duk-Woo Park, MD
Not yet recruiting --> Recruiting Initiation date: Sep 2020 --> Dec 2020
- ||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P1 trial: A Study to Explore Pharmacokinetics/Pharmacodynamics and Safety of Tegoprazan BID Dosing in Healthy Subjects (clinicaltrials.gov) - Oct 14, 2020
P1, N=64, Not yet recruiting, Sponsor: HK inno.N Corporation
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P1 trial: Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers (clinicaltrials.gov) - Sep 28, 2020
P1, N=16, Not yet recruiting, Sponsor: Seoul National University Hospital
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P1 trial: A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls (clinicaltrials.gov) - Aug 6, 2020
P1, N=28, Not yet recruiting, Sponsor: HK inno.N Corporation
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
Phase classification: PROTECT-HBR: Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy (clinicaltrials.gov) - Jul 22, 2020
P4, N=2500, Not yet recruiting, Sponsor: Duk-Woo Park, MD
Initiation date: Sep 2020 --> Dec 2020 Phase classification: P3 --> P4
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P4 trial: Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia (clinicaltrials.gov) - Jun 25, 2020
P4, N=60, Not yet recruiting, Sponsor: Asan Medical Center
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion: Effect of Tegoprazan or RAPA114 on Pharmacokinetic of Atorvastatin in Healthy Adult Volunteers (clinicaltrials.gov) - Jun 18, 2020
P1, N=32, Completed, Sponsor: CJ HealthCare Corporation
Phase classification: P3 --> P4 Recruiting --> Completed
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P3 trial, New P4 trial: PROTECT-HBR: Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy (clinicaltrials.gov) - Jun 3, 2020
P3, N=2400, Not yet recruiting, Sponsor: Duk-Woo Park, MD
- ||||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion: Triple Therapy With Tegoprazan in H. Pylori Positive Patients (clinicaltrials.gov) - May 7, 2020
P3, N=284, Completed, Sponsor: CJ HealthCare Corporation
Recruiting --> Completed Recruiting --> Completed
- |||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Enrollment open: Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT (clinicaltrials.gov) - May 7, 2020
P3, N=102, Recruiting, Sponsor: CJ HealthCare Corporation
Recruiting --> Completed Not yet recruiting --> Recruiting
- || K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion: Effect of Tegoprazan or RAPA113 on Pharmacodynamics/Pharmacokinetics of Clopidogrel in Healthy Male Volunteers (clinicaltrials.gov) - May 7, 2020
P1, N=36, Completed, Sponsor: CJ HealthCare Corporation
Not yet recruiting --> Recruiting Recruiting --> Completed
- ||||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion, Trial completion date, Trial primary completion date: Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive Esophagitis (clinicaltrials.gov) - Apr 15, 2020
P3, N=261, Completed, Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Recruiting --> Completed Recruiting --> Completed | Trial completion date: Jul 2020 --> Oct 2019 | Trial primary completion date: Feb 2020 --> Oct 2019
- ||||||| K-CAB Tab (tegoprazan) / RaQualia, Sebela
Trial completion, Trial completion date: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo Controlled Phase III Study to Evaluate the Efficacy and Safety of LXI-15028 in Non-erosive Reflux Disease in Chinese Patients for 4 Weeks (clinicaltrials.gov) - Apr 7, 2020
P3, N=291, Completed, Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Recruiting --> Completed | Trial completion date: Jul 2020 --> Oct 2019 | Trial primary completion date: Feb 2020 --> Oct 2019 Recruiting --> Completed | Trial completion date: Apr 2020 --> Nov 2019
- | K-CAB Tab (tegoprazan) / RaQualia, Sebela
New P4 trial: Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance (clinicaltrials.gov) - Mar 16, 2020
P4, N=46, Not yet recruiting, Sponsor: CJ HealthCare Corporation
- || Pizensy (lactitol) / Sebela
New Drug Trials Snapshot available for Pizensy (lactitol): https://t.co/CnGeBGMGRl. (Twitter) - Feb 27, 2020