Bioequivalence Study for Donepezil Hydrochloride 10 mg Tablets Under Fasting Condition

NCT ID: NCT01504503

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2009-12-31

Brief Summary

This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study.

Detailed Description

The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study of Donepezil Hydrochloride tablets 10 mg of Dr. Reddy's Laboratories Limited, India comparing with that of ARICEPT® (containing Donepezil Hydrochloride) tablets 10 mg of Pfizer Inc, New York, 10017 in healthy, adult, human subjects under fasting condition. 28 subjects are enrolled in the study, and 26 subjects are completed the study.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Donepezil Hydrochloride10 mg Tablets

Donepezil Hydrochloride 10 mg Tablets of Dr. Reddy's Laboratories Limited

Group Type: EXPERIMENTAL

Donepezil Hydrochloride

Intervention Type: DRUG

Donepezil Hydrochloride Tablets 10 mg

Aricept 10 mg Tablets

Aricept 10 mgTablets of Pfizer Inc

Group Type: ACTIVE_COMPARATOR

Aricept

Intervention Type: DRUG

Aricept 10 mg Tablets

Interventions

Donepezil Hydrochloride

Donepezil Hydrochloride Tablets 10 mg

Intervention Type: DRUG

Aricept

Aricept 10 mg Tablets

Intervention Type: DRUG

Other Intervention Names

Aricept 10 mg

Eligibility Criteria

Inclusion Criteria

• Provide written informed consent.
• Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg.
• Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in Kg/height in m2.
• Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance).
• Female Subjects

• Of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
• Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria

• Incapable of understanding the informed consent.
• Systolic blood pressure less than 90 mm of Hg 140 mm of Hg.
• Diastolic blood pressure less than 60 mm of Hg 90 mm of Hg.
• Oral temperature is below 95.0°F or above 98.6°F.
• Pulse rate below 50/min or above 100/min.
• History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
• Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
• Consumption of grapefruit for the past ten days prior to the check-in, in each period.
• Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
• Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
• Difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
• Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
• Clinically significant abnormalities and / or with significant diseases.
• Confirmed positive in alcohol screening.
• Confirmed positive in selected drug of abuse.
• Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
• Confirmed positive in urine pregnancy test.
• Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. L Krishna Murthy

Role: PRINCIPAL_INVESTIGATOR

Bioserve Clinical Research Private Limited

Locations

Bioserve Clinical Research Private Limited

Hyderabad, Andhra Pradesh, India

Countries

India

Other Identifiers

645/09

Identifier Type: -

Identifier Source: org_study_id