NCT02518451

Bioequivalence Evaluation of Two Film-Coated Formulations of Valsartan 160 mg

Bioequivalence Study of 160 mg Valsartan Film-coated Caplets Produced by PT Dexa Medica in Comparison With the Innovator Film-coated Tablets (Diovan® 160, Novartis Pharma AG)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This was a randomized, single-blind, two-period, two sequence cross-over study under fasting condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated caplets.

Detailed description

In the first period, subjects received either the test formulation (160 mg valsartan film-coated caplets produced by PT Dexa Medica, Palembang, Indonesia) once daily, or the innovator film-coated tablets (Diovan® 160, Novartis Farmaceutica S.A., Barbera del Valles, Spain for Novartis Pharma AG, Basel, Switzerland) once daily as the reference formulation. In the subsequent period, after a one-week wash-out period, they received the alternate drug. At the night before starting the study, subjects were instructed to fast from any food and drink but mineral water for 9 hours before the drug administration. In the morning after, at the dosing day, each of the 48 subjects then swallowed (without chewing) one dose of valsartan 160 mg of the test formulation or of the reference formulation, with 200 mL of water. As much as 5 mL of blood samples for drug assay were drawn again from each subject, at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 16, 24, 36, and 48 hours after dosing. The concentrations of valsartan in plasma were assayed using a validated high performance liquid chromatography with fluorescence detector (HPLC-FL) method. Pharmacokinetic parameters, including the area under the concentration-versus-time curve (AUC) from time zero to the time of last quatifiable concentration (48 hours after dosing) (AUC-t), AUC from time zero extrapolated to infinity (AUC-inf), maximum concentration (Cmax), time to reach the maximum concentration (tmax), and half-life (t1/2), were assessed in this study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Valsartan 160 mg film-coated caplets (test formulation)	In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.
DRUG	Valsartan 160 mg film-coated caplets (reference formulation)	In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-10-01
• Completion: 2014-03-01
• First posted: 2015-08-07
• Last updated: 2015-08-07

Locations

1 site across 1 country: Indonesia