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- || yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
Trial completion, Trial completion date, Trial primary completion date: Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD (clinicaltrials.gov) - Oct 27, 2022
P1, N=16, Completed, Sponsor: Sunshine Lake Pharma Co., Ltd.
Recruiting --> Completed | Trial completion date: Oct 2022 --> May 2022 | Trial primary completion date: Oct 2022 --> May 2022
- || yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects (clinicaltrials.gov) - Oct 27, 2022
P1, N=16, Completed, Sponsor: Sunshine Lake Pharma Co., Ltd.
Recruiting --> Completed | Trial completion date: Oct 2022 --> May 2022 | Trial primary completion date: Oct 2022 --> May 2022 Recruiting --> Completed | N=32 --> 16 | Trial completion date: Oct 2022 --> Jun 2022 | Trial primary completion date: Sep 2022 --> Jun 2022
- || yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
Enrollment open, Trial initiation date: Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD (clinicaltrials.gov) - May 6, 2021
P1, N=16, Recruiting, Sponsor: Sunshine Lake Pharma Co., Ltd.
Recruiting --> Completed | N=32 --> 16 | Trial completion date: Oct 2022 --> Jun 2022 | Trial primary completion date: Sep 2022 --> Jun 2022 Not yet recruiting --> Recruiting | Initiation date: Oct 2020 --> Apr 2021
- ||| yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
Trial completion: To Evaluate Efficacy and Safety in TG-2349 Combination With DAG181 ( (clinicaltrials.gov) - Feb 18, 2021
P2, N=133, Completed, Sponsor: Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
Not yet recruiting --> Recruiting | Initiation date: Oct 2020 --> Apr 2021 Recruiting --> Completed
- || yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma
Clinical, PK/PD data, Journal: Population Pharmacokinetic Analysis of Yimitasvir in Chinese Healthy Volunteers and Patients With Chronic Hepatitis C Virus Infection. (Pubmed Central) - Feb 16, 2021
Food decreased Ka and F significantly, so it was recommended to take yimitasvir at least 2 h before or after a meal. Other significant covariates were not clinically important.
- ||||||| yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
Trial completion, Combination therapy: A Phase III Study to Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and RBV for HCV Type I Patients (clinicaltrials.gov) - Feb 3, 2021
P3, N=370, Completed, Sponsor: Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
Other significant covariates were not clinically important. Recruiting --> Completed
- || Sovaldi (sofosbuvir) / Gilead, yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma
Clinical, Journal: Evaluation of drug-drug interactions between yimitasvir phosphate capsules with sofosbuvir tablets, omeprazole magnesium enteric-coated tablets, and rosuvastatin calcium tablets (Pubmed Central) - Oct 30, 2020
There were no serious adverse events and adverse events leading to withdrawal from the trial. Yimitasvir phosphate capsules have drug-drug interactions with sofosbuvir tablets, omeprazole magnesium enteric-coated tablets, and rosuvastatin calcium tablets.
- || yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
New P1 trial: Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD (clinicaltrials.gov) - Sep 24, 2020
P1, N=16, Not yet recruiting, Sponsor: Sunshine Lake Pharma Co., Ltd.
- || yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
New P1 trial: To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects (clinicaltrials.gov) - Sep 16, 2020
P1, N=32, Recruiting, Sponsor: Sunshine Lake Pharma Co., Ltd.
- |||||||||| yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
New P3 trial, Combination therapy: A Phase III Study to Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and RBV for HCV Type I Patients (clinicaltrials.gov) - Nov 13, 2019
P3, N=360, Recruiting, Sponsor: Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
- | Sovaldi (sofosbuvir) / Gilead, yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
Trial completion: Phase 3 Study of Yimitasvir Phosphate Capsules (clinicaltrials.gov) - Aug 1, 2019
P3, N=362, Completed, Sponsor: Sunshine Lake Pharma Co., Ltd.
Yimitasvir phosphate capsules have drug-drug interactions with sofosbuvir tablets, omeprazole magnesium enteric-coated tablets, and rosuvastatin calcium tablets. Active, not recruiting --> Completed
- ||||| Sovaldi (sofosbuvir) / Gilead, yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
Enrollment closed: Phase 3 Study of Yimitasvir Phosphate Capsules (clinicaltrials.gov) - Apr 10, 2019
P3, N=362, Active, not recruiting, Sponsor: Sunshine Lake Pharma Co., Ltd.
Active, not recruiting --> Completed Not yet recruiting --> Active, not recruiting
- | Sovaldi (sofosbuvir) / Gilead, yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
Trial completion: Phase 2 Study of Yimitasvir Phosphate Capsules (clinicaltrials.gov) - Aug 22, 2018
P2, N=129, Completed, Sponsor: Sunshine Lake Pharma Co., Ltd.
Not yet recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
New P1 trial: To Evaluate PK and Safety Profile of Oral MAD of Separately Using TG-2349, DAG181 or Combination in Healthy Chinese Volunteers (clinicaltrials.gov) - Aug 1, 2018
P1, N=24, Completed, Sponsor: Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
- | yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
New P2 trial: To Evaluate Efficacy and Safety in TG-2349 Combination With DAG181 ( (clinicaltrials.gov) - Jul 19, 2018
P2, N=132, Recruiting, Sponsor: Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
- || yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
New P1 trial: The Safety, Tolerability and Pharmacokinetic Study of Yimitasvir in Healthy Adults Subjects (clinicaltrials.gov) - Jul 15, 2018
P1, N=32, Completed, Sponsor: Sunshine Lake Pharma Co., Ltd.
- |||||||||| Sovaldi (sofosbuvir) / Gilead, yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
New P3 trial: Phase 3 Study of Yimitasvir Phosphate Capsules (clinicaltrials.gov) - Apr 2, 2018
P3, N=360, Not yet recruiting, Sponsor: Sunshine Lake Pharma Co., Ltd.
- ||||| Sovaldi (sofosbuvir) / Gilead, yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
New P2 trial: Phase 2 Study of Yimitasvir Phosphate Capsules (clinicaltrials.gov) - Mar 8, 2018
P2, N=129, Active, not recruiting, Sponsor: Sunshine Lake Pharma Co., Ltd.