Trials / Completed
CompletedNCT00834379
Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions
A Relative Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Teva Pharmaceuticals USA · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to compare the relative bioavailability of pravastatin sodium 40 mg tablets with that of Pravachol® 40 mg tablets in healthy adult male subjects under fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pravastatin sodium | 40 mg Tablet |
| DRUG | Pravachol® | 40 mg tablet |
Timeline
- Start date
- 2000-09-01
- Primary completion
- 2000-09-01
- Completion
- 2000-09-01
- First posted
- 2009-02-03
- Last updated
- 2020-10-08
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00834379. Inclusion in this directory is not an endorsement.