Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-03 @ 3:48 AM
Study NCT ID:
NCT02197494
Status:
COMPLETED
Last Update Posted:
2014-07-22
First Post:
2014-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Valsartan 320mg Tablets Under Fed Conditions
Sponsor:
Ranbaxy Laboratories Limited
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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including pre-dose sample (duplicate), each of 02 mL, were collected from each subject except for the discontinued / withdrawn subjects to analyze the pharmacokinetic profile of the test as well as the reference drug.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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: