Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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
Phase:
Phase 1
Details
Lead Sponsor:
Torrent Pharmaceuticals Limited
Treatments:
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate