Clinical Trials Logo
  1. Home
  2. Therapeutic Equivalency
  3. NCT00648544

Fed, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Subjects

Therapeutic Equivalency Clinical Trial

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

Clinical Trial Summary

This study was designed to compare the rate and extent of absorption of pravastatin sodium from the following formulations under fed conditions: 1. Pravastatin Sodium 80 mg Tablets (Genpharm Inc. Canada) 2. Pravachol® 80 mg Tablets (Bristol-Myers Squibb Co., U.S.A.) Bioequivalence of these formulations was assessed for pravastatin. Based on the results from this study, these two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fed conditions.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00648544
Study type Interventional
Source Viatris Inc.
Contact
Status Completed
Phase Phase 1
Start date July 2003
Completion date July 2003
View Details
See also
  Status Clinical Trial Phase
Completed NCT04467346 - Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules Phase 1
Completed NCT00807118 - Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect Phase 1
Withdrawn NCT01405170 - A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions Phase 1
Completed NCT04885660 - Bioequivalence Evaluation of Two Fixed-dose Combination of Lisinopril 10mg/Levamlodipine Besylate 5mg in Healthy Chinese Subjects Phase 1
Completed NCT05786339 - Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects Phase 1
Completed NCT00709189 - Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women. Phase 1
Completed NCT00658541 - Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets Phase 1
Completed NCT00685165 - Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets Phase 1
Completed NCT00997789 - Bioequivalence of Rebamipide in Korean N/A
Completed NCT00684762 - Fasted Bioavailability Study of Cilostazol Tablets, 100 mg Phase 1
Recruiting NCT04814589 - Bioequivalence of Ezetimibe Tablets in Healthy Subjects Phase 1
Completed NCT03631316 - Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir N/A
Recruiting NCT04438720 - Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects Phase 1
Completed NCT01359163 - A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects Phase 1
Completed NCT00650221 - Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects Phase 1
Completed NCT05225974 - A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects Phase 1
Withdrawn NCT01405131 - A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Phase 1
Withdrawn NCT01405157 - A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions Phase 1
Completed NCT05282940 - Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product Phase 1
Completed NCT06050343 - Comparative Study of Rinsulin R (GEROPHARM) and Humulin Regular (Eli Lilly) Euglycemic Hyperinsulinemic Clamp Method N/A