NCT02680119

BE of Torrent's Esomeprazole Mg DR Capsules

An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE Study of Esomeprazole Mg DR Capsule 40 mg [Torrent] Versus Nexium [AastraZeneca]- Sprinkled Over Apple Sauce in Subjects-Fasting 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 Mg DR Capsule 1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 5 days.

Detailed description

An open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Mg DR Capsule containing Esomeprazole Mg 40 mg \[ Test Formulation, Torrent Pharmaceutical Ltd., India\] Versus Nexium 40 mg DR Capsule containing Esomeprazole 40 mg \[Reference Formulation, AastraZeneca LP, USA\] Under administered as the contents of capsule sprinkled over apple sauce in Healthy Human Volunteers Under Fasting Condition.

Conditions

• Healthy

Interventions

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

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