Completed PHASE1 INTERVENTIONAL 2-arm NCT00650221

Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects

A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Non-Smoking Male and Female Subjects

Sponsor: Genpharm ULC

Conditions Therapeutic Equivalency

Interventions Pravastatin

Updated 9 times since 2017 Last updated: Apr 22, 2024 Started: Jun 30, 2003 Primary completion: Jul 31, 2003 Completion: Jul 31, 2003

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Therapeutic Equivalency, this trial is completed. The trial is conducted by Genpharm ULC and has accumulated 9 data snapshots since 2003. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

9 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
May 2024 — Jul 2024 [monthly]

Completed PHASE1
Nov 2022 — May 2024 [monthly]

Completed PHASE1
Mar 2022 — Nov 2022 [monthly]

Completed PHASE1

▶ Show 4 earlier versions

Jan 2021 — Mar 2022 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Jun 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Genpharm ULC
Mylan Pharmaceuticals Inc

Data source: Viatris Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Toronto, Canada