Bioequivalence Study of Valsartan 320mg Tablets Under Fasting Conditions

NCT02197442 | Completed

• 1 other identifier: 044-14
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study was an open label, balanced, randomized, two-treatment, four-period, two sequence, single oral dose, crossover, fully replicate bioequivalence study of two formulations of Valsartan 320 mg under fasting conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Valsartan

  0-36 hrs

Study Arms (2)

Test

EXPERIMENTAL

Valsartan Tablets USP 320 mg DIVIS

Drug: Valsartan

Reference

ACTIVE COMPARATOR

Diovan® (Valsartan) 320 Tablets

Drug: Valsartan

Interventions

Valsartan DRUG

Also known as: 320mg tablets

Reference; Test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, human volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
• Having a Body Mass Index (BMI) between 18.5-24.9 (both inclusive), calculated as weight in kg/height in meter2.
• Not having any significant disease in medical history or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.
• Able to understand and comply with the study procedures, in the opinion of the investigator.
• Able to give voluntary written informed consent for participation in the trial.
• In case of female subjects:
• Surgically sterilized at least 6 months prior to study participation; Or
• If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
• And
• Pregnancy test must be negative.

You may not qualify if:

• Known hypersensitivity or idiosyncratic reaction to valsartan or any of the formulation excipients or any related drug.
• History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
• Sitting blood pressure less than 110 /70 mm Hg and pulse rate less than 60 or more than 100 beats per minute at the time of screening.
• Presence of orthostatic hypotension.
• If the QTc interval were to be more than 450 ms on ECG measurement at the time of screening.
• Inability to remain in an upright position at the time of dosing.
• Ingestion of a medicine (including herbal remedies) at any time within 14 days before dosing in period-I. In any such case subject selection were at the discretion of the Principal Investigator.
• Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
• A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine.
• Smokers, who smoke 10 or more than 10 cigarettes/day or inability to abstain from smoking during the study.
• The presence of clinically significant abnormal laboratory values during screening.
• Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
• History or presence of psychiatric disorders.
• A history of difficulty in donating blood.
• Note: In case the blood loss is ≤ 200 mL; subject may be dosed 60 days after blood donation or last sample of the previous study.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Lambda Therapeutic Research Ltd.,

Ahmedabad, Gujarat, 380 061, India

Location

Related Links

• Related Info
• Related Info

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 22, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

IN (1)