NCT02680132

Bioequivalence Study of Torrent Pharmaceutical Ltd's Esomeprazole Magnesium Delayed Release Capsules

An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Esomeprazole Mg DR Capsule 40 mg [Torrent,India] Versus Nexium 40 mg DR Capsule [ AastraZeneca LP, USA] in Healthy Subjects-Fed Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Delayed Release Capsule 1 × 40 mg and Nexium 1× 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 7 days.

Detailed description

An Open Label, Randomized, 2 -Period, 2-Treatment, 2 Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Delayed Release Capsule 40 mg \[Test Formulation, Torrent Pharmaceutical Ltd., India\]Versus Nexium 40 mg Delayed Release Capsule containing Esomeprazole 40 mg. \[Reference Formulation, AastraZeneca LP, USA\] in Healthy Human Volunteers Under Fed Conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nexium 40 mg DR Capsules of AstraZeneca LP, USA	oral, cross over
DRUG	Torrent's Esomeprazole Magnesium DR Capsules 40 mg	oral, cross over

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2016-02-11
• Last updated: 2016-02-11