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A Relative Bioavailability Study of Propranolol Hydrochloride 160 mg Tablets Under Fasting Conditions

NCT00865215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-08-17

No results posted yet for this study

Summary

The purpose of this study is TO compare the relative bioavailability of Propranolol Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult volunteers under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Propranolol Hydrochloride Extended Release Capsules 160 mg

A: Experimental Subjects received Actavis formulated products under fasting conditions

DRUG

INDERAL® LA 160 mg Capsules, single dose

B: Active comparator Subjects received Wyeth Pharmaceuticals formulated products under fasting conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2005-04-30
Completion
2005-04-30

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 NCT00865215 on ClinicalTrials.gov