| Palexia RP (tapentadol extended release) / Assertio, J&J, Grunenthal, Collegium Pharma |
NCT03951402: Effect of a Multiple-dose Oral Administration of CG5503 PR on the Electrical Activity of the Heart in 48 Healthy Men and Women |
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| Completed | 1 | 48 | Europe | 100 mg CG5503 (tapentadol hydrochloride) PR tablet, Placebo matching CG5503 PR tablet, Placebo matching moxifloxacin capsule, 400 mg Moxifloxacin tablet (overencapsulated) | Grünenthal GmbH | Prolonged QTc Interval, Pharmacokinetic | 08/03 | 08/03 | | |
NCT03956134: Pharmacokinetic Characterization of Two Novel CG5503 Tablet Formulations in Healthy Volunteers |
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| Completed | 1 | 10 | Europe | Tapentadol Test Product 1, Tapentadol Test Product 2, Tapentadol Prolonged-release Reference Product | Grünenthal GmbH | Pharmacokinetics | 06/05 | 06/05 | | |
NCT01877226: Phase 1 Pharmacokinetic Study of Tapentadol Prolonged-Release 250 Milligram (mg) Formulation in Healthy Participants |
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| Completed | 1 | 18 | Europe | Tapentadol | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Healthy | 10/08 | 10/08 | | |
NCT01981278: A Study to Assess Bioequivalence of a New Tapentadol Extended-Release 250-mg Tablet With Respect to a Tapentadol Extended-Release 250-mg Tablet in Healthy Participants |
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| Completed | 1 | 63 | US | Tapentadol ER 250-mg TRF tablet, Tapentadol ER 250-mg PR2 tablet | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Healthy | 08/10 | 08/10 | | |
NCT01900587: A Pivotal Study to Evaluate the Bio-equivalence of the Tapentadol Extended-Release (ER) Tamper-resistant Formulation (TRF) Tablet to the Current Tapentadol ER Prolonged-release 2 (PR2) Tablet |
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| Completed | 1 | 64 | US | Tapentadol ER Tamper-resistant Formulation (TRF), Tapentadol ER Prolonged-Release 2 (PR2) | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Healthy | 08/10 | 08/10 | | |
NCT02019485: A Study to Assess Bioequivalence of a New Tapentadol Extended-Release Tablet With Respect to a Tapentadol Extended Release Tablet Under Fasted Conditions in Healthy Subjects |
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| Completed | 1 | 64 | US | Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF), Tapentadol Prolonged-Release Formulation 2 (PR2) | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Healthy | 08/10 | 08/10 | | |
NCT01273506: A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 25-mg Tablets Relative to One 50-mg Tablet |
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| Completed | 1 | 30 | US | tapentadol (CG5503) ER 25-mg TRF, tapentadol (CG5503) ER 50-mg TRF | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Healthy Volunteer | | 02/11 | | |
NCT01273532: A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 50-mg Tablets Relative to One 100-mg Tablet |
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| Completed | 1 | 30 | US | tapentadol (CG5503) ER 100-mg TRF, tapentadol (CG5503) ER 50-mg TRF | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Healthy Volunteer | | 03/11 | | |
NCT01309425: A Study to Compare the Dose-proportionality of Tapentadol (CG5503) in Healthy Japanese and Korean Male Volunteers |
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| Completed | 1 | 52 | US | tapentadol (CG5503) ER two 100-mg TRF, tapentadol (CG5503) ER 50-mg TRF, tapentadol (CG5503) ER 25-mg TRF, tapentadol (CG5503) ER 100-mg TRF | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Healthy Volunteer | | 05/11 | | |
2012-005499-33: Comparison of blood concentrations of tapentadol from 4 prolonged release formulations (3 granule formulations and 1 tablet formulation) in healthy adult subjects. |
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| Completed | 1 | 48 | Europe | Tapentadol 25 mg prolonged-release granules 15% coating level, Tapentadol 25 mg prolonged-release granules 20% coating level, Tapentadol 25 mg prolonged-release granules 25% coating level, CG5503, Palexia retard 25mg Retardtabletten, Palexia retard 25mg Retardtabletten | Grünenthal GmbH, Grünenthal GmbH | No medical condition to be investigated. | | 06/15 | | |
