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Food Study of Propranolol Hydrochloride Extended-Release Capsules 160 mg and Inderal® LA Capsules 160 mg

NCT00647608 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2024-04-24

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Mylan's propranolol hydrochloride extended-release 160 mg capsules to Wyeth's Inderal® LA 160 mg capsules following a single, oral 160 mg (1 x 160 mg) dose administered under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Propranolol Hydrochloride Extended-Release Capsules 160 mg

160mg, single dose fed

DRUG

Inderal® LA Capsules 160 mg

160mg, single dose fed

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • James D Carlson, Pharm. D. · PRACS Institute Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2005-10-31
Completion
2005-10-31

Countries

  • United States

Study Locations

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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 NCT00647608 on ClinicalTrials.gov