NCT02197442

Bioequivalence Study of Valsartan 320mg Tablets Under Fasting Conditions

An Open Label, Balanced, Randomized, Two-treatment, Four-period, Two-sequence, Single Oral Dose, Crossover, Fully Replicate Bioequivalence Study of Two Formulations of Valsartan 320 mg Tablet in Healthy, Adult, Human Subjects Under Fasting Condition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study was an open label, balanced, randomized, two-treatment, four-period, two sequence, single oral dose, crossover, fully replicate bioequivalence study of two formulations of Valsartan 320 mg under fasting conditions.

Detailed description

Tablet in healthy, adult human subjects under fasting condition, with a screening period of 28 days prior to dose administration in Period-I. In each study period, twenty-four (24) blood samples, including two (02) predose blood samples, each of 02 mL were collected from each subject except for the discontinued / withdrawn subjects to analyze the pharmacokinetic profile of the test as well as the reference product. The pharmacokinetic parameters were calculated from the drug concentration vs. time profile by non-compartmental model using WinNonlin Professional Software-Version 5.3 (Pharsight Corporation, USA) for Valsartan. Statistical comparison of the pharmacokinetic parameters of the two formulations was carried out using PROC MIXED of SAS® Version 9.3 (SAS Institute Inc., USA) to assess the bioequivalence of both the formulations.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Valsartan

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2014-07-22
• Last updated: 2014-07-22

Locations

1 site across 1 country: India