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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of at least 7 days.

Study Design:

Randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Torrent Pharmaceuticals Limited
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• 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 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 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.