Bioequivalence Study of Valsartan 320mg Tablets Under Fasting Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02197442
• Date of registration: 21/07/2014
• Prospective Registration: No
• Primary sponsor: Ranbaxy Laboratories Limited
• Public title: Bioequivalence Study of Valsartan 320mg Tablets Under Fasting Conditions
• Scientific title: 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 Tablet in Healthy, Adult, Human Subjects Under Fasting Condition
• Date of first enrolment: January 2014
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02197442
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
• Phase: N/A

Countries of recruitment

India

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Healthy, adult, human volunteers between 18 to 45 years of age (both inclusive)
living in and around Ahmedabad city or western part of India.

2. Having a Body Mass Index (BMI) between 18.5-24.9 (both inclusive), calculated as
weight in kg/height in meter2.

3. 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.

4. Able to understand and comply with the study procedures, in the opinion of the
investigator.

5. Able to give voluntary written informed consent for participation in the trial.

6. 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 Criteria:

1. Known hypersensitivity or idiosyncratic reaction to valsartan or any of the
formulation excipients or any related drug.

2. 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.

3. 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.

4. Presence of orthostatic hypotension.

5. If the QTc interval were to be more than 450 ms on ECG measurement at the time of
screening.

6. Inability to remain in an upright position at the time of dosing.

7. 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.

8. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp
or NSAIDs induced urticaria.

9. 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.

10. Smokers, who smoke 10 or more than 10 cigarettes/day or inability to abstain from
smoking during the study.

11. The presence of clinically significant abnormal laboratory values during screening.

12. Use of any recreational drugs or history of drug addiction or testing positive in pre
study drug scans.

13. History or presence of psychiatric disorders.

14. A history of difficulty in donating blood.

15. 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.

16. A positive hepatitis screen including hepatitis B surface antigen and/or HCV
antibodies.

17. A positive test result for HIV antibody.

18. 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.

19. Consumption of grapefruit or grapefruit products within 48 hours prior to dosing.

20. Nursing mothers (females).



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Valsartan

Primary Outcome(s)

Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Valsartan [Time Frame: 0-36 hrs]

Secondary ID(s)

044-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors