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Bioequivalence Study for Donepezil Hydrochloride 10 mg Tablets Under Fasting Condition

Sponsor
Dr. Reddy's Laboratories Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT01504503
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
2
Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 10 mg in Healthy, Adult, Human Subjects Under Fasting Condition.
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Donepezil Hydrochloride10 mg Tablets

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

Drug: Donepezil Hydrochloride
Donepezil Hydrochloride Tablets 10 mg
Other Names:
  • Aricept 10 mg

    		•
    Active Comparator: Aricept 10 mg Tablets

    Aricept 10 mgTablets of Pfizer Inc

    Drug: Aricept
    Aricept 10 mg Tablets

    Outcome Measures

    Primary Outcome Measures

    1. Area unde curve (AUC) [Pre-dose 0.5,0.75,1,1.5,2,2.5,3,3.5,4,4.5,5,5.5,6,7,8,9,10,12,16,24,36,48,72,96,120,144,168,192,216,240 and 264 hours post-dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bioserve Clinical Research Private Limited Hyderabad Andhra Pradesh India 500 037

    Sponsors and Collaborators

    • Dr. Reddy's Laboratories Limited

    Investigators

    • Principal Investigator: Dr. L Krishna Murthy, Bioserve Clinical Research Private Limited

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Reddy's Laboratories Limited
    ClinicalTrials.gov Identifier:
    NCT01504503
    Other Study ID Numbers:
    • 645/09
    First Posted:
    Jan 5, 2012
    Last Update Posted:
    Jan 6, 2012
    Last Verified:
    Sep 1, 2009
    Keywords provided by Dr. Reddy's Laboratories Limited
    Bioequivalence
    Donepezil
    crossover
    Additional relevant MeSH terms:
    Donepezil

    Study Results

    No Results Posted as of Jan 6, 2012