Overview

Bioequivalence Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochloride Tablets Under Fasting Conditions.

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
Male
Summary
Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22 days.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Torrent Pharmaceuticals Limited
Treatments:
Amlodipine
Hydrochlorothiazide
Olmesartan
Olmesartan Medoxomil
Criteria
Inclusion Criteria:

- Sex: male

- Age: 18-45 years

- Volunteer with BMI of 18-25 (inclusive both) kg/m2

- Healthy and willing to participate in the study.

- Volunteer willing to adhere to the protocol requirements and to provide written
informed consent.

- Preferably Non-smokers

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

- Clinically relevant abnormalities in the results of the laboratory screening
evaluation.

- Clinically significant abnormal ECG or Chest X-ray.

- Systolic blood pressure less than 110 mm Hg or more than 140 mm Hg and diastolic blood
pressure less than 70 mm Hg or more than 90 mm Hg.

- Pulse rate less than 60/minute or more than 100/minute. Oral temperature less than
95°F or more than 99°F.

- Respiratory rate less than 14/minute or more than 18/minute

- History of allergy to the test drug or any drug chemically similar to the drug under
investigation.

- History of alcohol or drug abuse

- Positive breath alcohol test

- Recent history of kidney or liver dysfunction.

- History of consumption of prescribed medication since last 14 days or OTC medication
since last 07 days before beginning of the study.

- Volunteers suffering from any chronic illness such as arthritis, asthma etc.

- History of heart failure.

- HIV, HCV, HBsAg positive volunteers.

- Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine
positive volunteers based on urine test.

- Volunteers suffering from any psychiatric (acute or chronic) illness requiring
medications.

- Administration of any study drug in the period 0 to 3 months before entry to the
study.

- History of significant blood loss due to any reason, including blood donation in the
past 3 months.

- History of pre-existing bleeding disorder.

- Existence of any surgical or medical condition, which, in the judgment of the chief
investigator and/or clinical investigator/physician, might interfere with the
absorption, distribution, metabolism or excretion of the drug or likely to compromise
the safety of volunteers.

- Inability to communicate or co-operate due to language problem, poor mental
development or impaired cerebral function.