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

NCT01419340 | Completed Phase 1

• 1 other identifier: PK-07-116
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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® 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• bioequivalence based on Composite of Pharmacokinetics

  bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.

Interventions

Torrent's Donepezil Hydrochloride Tablets 10mg DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

Study Sites (1)

Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,

Village Bhat, Gandhinagar, Gujarat, 382428, India

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 18, 2011
• Last Updated: August 18, 2011

Record last verified: 2011-08

Locations

IN (1)