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Pravastatin Sodium 80 mg Tablets Under Fasting Conditions

NCT00830258 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-19

Study results available
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Summary

The objective of this study is to evaluate the comparative bioavailability between pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80 mg tablets (Bristol Myers Squibb, USA), after a single-dose in healthy subjects under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Pravastatin sodium 80 mg tablets

1 x 80 mg

DRUG

Pravachol® 80 mg tablets

1 x 80 mg

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Xueyu (Eric) Chen, M.D.; Ph.D ; FRCP (C) · Pharma Medica Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Canada

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 NCT00830258 on ClinicalTrials.gov