NCT01418547

Bioequivalence Study of Torrent Pharmaceutical Limited's Isosorbide Mononitrate 120 mg ER Tablets Under Fed Conditions

An Open Label, Randomized, Two Treatment, Two Sequence, Two Period, Cross-over, Single-dose Comparative Oral Bioavailability Study of Isosorbide Mononitrate 120 mg ER Tablets (Test) of Torrent Pharmaceuticals Ltd., India and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA in Healthy, Adult, Male, Human Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Objective: to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA under fed condition. Dosing periods were separated by a washout period of 8 days. Study Design: randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Torrent's Isosorbide Mononitrate 120 mg ER Tablets

Timeline

• First posted: 2011-08-17
• Last updated: 2011-08-17

Locations

2 sites across 1 country: India