Status:
COMPLETED
Bioequivalence Study of Valsartan 320mg Tablets Under Fasting Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
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 u...
Detailed Description
Tablet in healthy, adult human subjects under fasting condition, with a screening period of 28 days prior to dose administration in Period-I. In each study period, twenty-four (24) blood samples, incl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
- 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.
- A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- A positive test result for HIV antibody.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine in period-I. In any such case subject selection were at the discretion of the Principal Investigator.
- Consumption of grapefruit or grapefruit products within 48 hours prior to dosing.
- Nursing mothers (females).
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02197442
Start Date
January 1 2014
End Date
March 1 2014
Last Update
July 22 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lambda Therapeutic Research Ltd.,
Ahmedabad, Gujarat, India, 380 061