Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fed Conditions

Status:

COMPLETED

Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fed Conditions

Lead Sponsor:

Torrent Pharmaceuticals Limited

Conditions:

Healthy

Eligibility:

MALE

18-45 years

Phase:

PHASE1

Brief Summary

Objective: To compare the rate and extent of release of the drug substance from the two tablet formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and the Aricept® ...

Eligibility Criteria

Inclusion

The volunteers were excluded from the study based on the following criteria:
Sex: male.
Age: 18 - 45 years. .
Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
Healthy and willing to participate in the study.
Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion

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 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
Pulse rate less than 50/minute or more than 100/minute.
Oral temperature less than 95°P or more than 98.6°P.
Respiratory rate less than 12/minute or more than 20/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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01419366

Last Update

August 23 2013

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)