Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition

Condition(s) targeted: Healthy

Intervention: Donepezil Hydrochloride (Drug); Aricept (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Dr. L Krishna Murthy, Principal Investigator, Affiliation: Bioserve Clinical Research Private Limited

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

Official title: Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Donepezil Hydrochloride Tablets 10mg With ARICEPT® (Containing Donepezil Hydrochloride) Tablets 10mg in Healthy, Adult, Human Subjects Under Fed Condition.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area under curve (AUC)

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 10mg of Dr. Reddy's Laboratories Limited, India comparing with that of ARICEPT® (containing Donepezil Hydrochloride) tablets 10mg of Pfizer Inc, New York, 10017 in healthy, adult, human subjects under fed condition. 28 subjects are enrolled in the study, 3 subjects are withdrawn from the study and 25 subjects are completed the study.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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 or more than 140 mm of Hg.

- Diastolic blood pressure less than 60 mm of Hg or more than 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.

Bioserve Clinical Research Private Limited, Hyderabad, Andhra Pradesh 500 037, India

Starting date: October 2009
Last updated: January 5, 2012