Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-03 @ 3:46 PM
Study NCT ID:
NCT02518451
Status:
COMPLETED
Last Update Posted:
2015-08-07
First Post:
2015-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Evaluation of Two Film-Coated Formulations of Valsartan 160 mg
Sponsor:
Dexa Medica Group
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2015-08
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:
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.
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.
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?: