Completed
An open label, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine delayed release capsules 400 mg manufactured by Sun Pharmaceutical Industries Limited, India with Mesalamine Delayed-Release Capsules 400 mg, manufactured for Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, in healthy, adult, human subjects under fed condition.
2025-520618-76-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Ponatinib Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Iclusig (Ponatinib hydrochloride) tablets 15 mg, Produced by: Patheon Inc. Mississauga, Canada or Takeda Ireland Limited Bray, Ireland, Imported and registered by: Pint Pharma Medical-Hospital and Pharmaceutical Products Ltd. Nelson Pontes Street, 125, Block 03, Jardim Margarida Zip Code 06739-024, Vargem Grande Paulista – SP CNPJ No. 21,896,000/0001-91, in healthy adult, human subjects under fasting condition.
2025-524311-37-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Maribavir Tablets 200 mg, manufactured by Sun Pharmaceutical Industries Limited, India with LIVTENCITY® (Maribavir) Coated Tablets 200 mg, manufactured by: Catalent CTS, LLC Kansas City, United States of America, packed by: Takeda Ireland Limited Bray, Ireland, imported by: Takeda Pharma Ltda. Highway SP 340 S/N, km 133.5 Jaguariúna Administrative Building -SP CNPJ 60.397.775/0001-74 SAC: 0800 - 7710345, in healthy adult, human subjects under fasting condition.
2025-523487-21-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Deucravacitinib tablets 6 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with SOTYKTU (deucravacitinib) tablets 6 mg, Distributed by Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA, in healthy, adult, human subjects under fasting condition.
2025-523838-13-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Deucravacitinib tablets 6 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with SOTYKTU (deucravacitinib) tablets 6 mg, Distributed by Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA, in healthy, adult, human subjects under fed condition
2025-523839-18-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine delayed release capsules 400 mg manufactured by Sun Pharmaceutical Industries Limited, India with Mesalamine Delayed-Release Capsules 400 mg, manufactured for Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, in healthy, adult, human subjects under fasting condition.
2025-520617-31-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Ruxolitinib Tablets, 20 mg, manufactured by Sun Pharmaceutical Industries Limited, India with JAKAVI (ruxolitinib) tablets 20 mg, (each Jakavi 20 mg tablet contains 26.40 mg of ruxolitinib phosphate equivalent to 20 mg of ruxolitinib). Imported by: Novartis Biociências SA Av. Prof. Vicente Rao, 90 - São Paulo - SP CNPJ: 56.994.502/0001-30. Manufactured by: Novartis Pharma Stein AG, Stein – Switzerland, in healthy adult, human subjects under fasting condition.
2024-519801-36-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutamide film coated tablets 80 mg, Manufactured for Sun Pharmaceutical Industries Limited, India with XTANDI (Enzalutamide) 80 mg film coated tablets, Made by: Patheon Inc., 2100 Syntex Court, Mississauga, Ontario – Canada, Imported and registered by: Astellas Farma Brasil Importação e Distribuição de Medicamentos Ltda., São Paulo-SP, Brazil, in healthy adult, male subjects under fasting condition.
2024-518209-16-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutamide film coated tablets 160 mg, Manufactured for Sun Pharmaceutical Industries Limited, India with XTANDI (Enzalutamide) 80 mg film coated tablets, Made by: Patheon Inc., 2100 Syntex Court, Mississauga, Ontario – Canada, Imported and registered by: Astellas Farma Brasil Importação e Distribuição de Medicamentos Ltda., São Paulo-SP, Brazil, in healthy adult, male subjects under fasting condition.
2024-518211-20-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Brivaracetam Tablets Ph. Eur. 100 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Briviact (brivaracetam) 100 mg film-coated tablets, Marketing Authorisation Holder: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium; Manufactured by UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium, in healthy adult, human subjects under fasting condition.
2024-516500-42-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Lamotrigine Dispersible Tablets BP 100 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Lamictal (Lamotrigine) Dispersible Tablets 100 mg, Manufactured by: Delpharm Poznaÿ – Poland & Registered and Imported by: GlaxoSmithKline Brasil Ltda, in healthy adult, human subjects under fasting condition.
2024-513106-62-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, four period, two-sequence, multiple-dose (steady-state), fully-replicate crossover bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fasting condition.
2024-512770-10-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with RINVOQ 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fed condition.
2024-512771-12-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with RINVOQ 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fasting condition.
2024-512773-27-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Lacosamide tablets USP 200 mg, manufactured by Sun Laboratories Industries Limited, India with Vimpat (Lacosamide) 200 mg film-coated tablets, Marketing Authorisation Holder UCB Pharma S.A., Belgium, in healthy adult, human subjects under fasting condition.
2023-507991-32-00· Phase 1· Sun Pharmaceutical Industries Limited· Source
Completed
An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Ivacaftor film coated tablets 150 mg of Sun Pharmaceutical Industries Ltd, India with Kalydeco (Ivacaftor) 150 mg film-coated tablets, Marketing Authorisation Holder: Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland, in healthy adult, human subjects under fed condition.
2023-508115-23-00· Phase 1· Sun Pharmaceutical Industries Limited· Source