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

NCT02518451 | Completed

• 1 other identifier: PR. 183/EQL/2010
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

antihypertensive; bioequivalence; formulation; pharmakokinetic; valsartan; subjects; Fasting conditions

Outcome Measures

Primary Outcomes (3)

• AUCt

  Area under the curve of plasma concentrations versus time from time zero to the time of last observed quantifiable concentration was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations)

  48 hours

• AUCinf

  Area under the curve of plasma concentrations versus time from time zero to infinity was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations)

  48 hours

• Cmax

  The maximum (peak) plasma concentration was determined from plasma concentration of two valsartan160 mg film-coated caplets formulations (test and reference formulations)

  48 hours

Secondary Outcomes (2)

• Tmax

  48 hours

• T1/2

  48 hours

Other Outcomes (1)

• Adverse events

  1 months

Study Arms (2)

(Test) Group I

EXPERIMENTAL

Valsartan 160 mg film-coated caplets of PT Dexa Medica

Drug: Valsartan 160 mg film-coated caplets (test formulation)

(Reference) Group II

ACTIVE COMPARATOR

Valsartan 160 mg film-coated caplets (Diovan® 160)

Drug: Valsartan 160 mg film-coated caplets (reference formulation)

Interventions

Valsartan 160 mg film-coated caplets (test formulation) DRUG

In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.

Also known as: Valsartan 160 mg of PT Dexa Medica

(Test) Group I

Valsartan 160 mg film-coated caplets (reference formulation) DRUG

In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.

Also known as: Diovan® 160

(Reference) Group II

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.
• Aged 18 - 55 years inclusive
• Preferably non-smokers or smoke less than 10 cigarettes per day.
• Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
• Body mass index within 18 to 25 kg/m2.
• Vital signs (after 10 minutes rest) must be within the following ranges:
• Systolic blood pressure : 110 - 120 mm Hg
• Diastolic blood pressure : 70 - 80 mm Hg
• Pulse rate : 60 - 90 bpm

You may not qualify if:

• Personal/family history of allergy or hypersensitivity or contraindication to valsartan or allied drugs.
• Pregnant or lactating women (urinary pregnancy test will be applied to women subjects just before taking the study drug).
• Any major illness in the past 90 days or clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, hypotensive episodes, hyperglycemia, etc.
• Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (ALT, alkaline phosphatase, total bilirubin \>= 1.5 ULN), renal function test (serum creatinine concentration \> 1.4 mg/dL), etc.
• Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
• Clinically significant haematology abnormalities.
• Clinically significant electrocardiogram (ECG) abnormalities.
• Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery.
• Past history of anaphylaxis or angioedema.
• History of drug or alcohol abuse within 12 months prior to screening for this study.
• Participation in any clinical trial within the past 90 days calculated from the last visit.
• History of any bleeding or coagulative disorders.
• History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm.
• A donation or loss of 300 mL (or more) of blood within 3 months before this study's first dosing day.
• Intake of any prescription or non-prescription drug, food supplement or herbal medicine within 14 days of this study's first dosing day.

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (1)

PT Equilab International

Jakarta, Jakarta Special Capital Region, 12430, Indonesia

Location

MeSH Terms

Interventions

Valsartan

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Effi Setiawati, MSc

  PT Equilab International

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 7, 2015
• Study Start: June 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

ID (1)