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

NCT01418547 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2011-08-17

No results posted yet for this study

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

DRUG

Torrent's Isosorbide Mononitrate 120 mg ER Tablets

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • India

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01418547 on ClinicalTrials.gov