NCT02197494

Bioequivalence Study of Valsartan 320mg Tablets Under Fed Conditions

An Open Label, Balanced, Randomized, Two-treatment, Two Period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Two Formulations of Valsartan 320mg Tablet in Healthy, Adult, Human Subjects Under Fed Condition.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (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, two-period, two sequence, single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg under fed conditions.

Detailed description

After an overnight fast of at least 10 hours, the subjects were served a USFDA recommended high fat high calorie non-vegetarian breakfast, which they consumed within 30 minutes. A single oral dose (320 mg) of either the test or the reference product was administered to the subjects at 30 ± 2 minutes minutes after serving the USFDA recommended high fat high calorie non-vegetarian breakfast. The IMP was administered in sitting posture with 240 mL of drinking water at ambient temperature. The IMP administration was as per the randomization schedule and under open-label condition. A total of twenty-six (26) blood samples including pre-dose sample (duplicate), each of 02 mL, were collected from each subject except for the discontinued / withdrawn subjects to analyze the pharmacokinetic profile of the test as well as the reference drug. 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	320mg tablets

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