Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01504516
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : January 6, 2012
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

January 3, 2012
January 5, 2012
January 6, 2012
October 2009
November 2009   (Final data collection date for primary outcome measure)
Area under curve (AUC) [ Time Frame: 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 ]
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01504516 on Archive Site
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Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition
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.
This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study.
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10017 in healthy, adult, human subjects under fed condition. 28 subjects are enrolled in the study, 3 subjects are withdrawn from the study and 25 subjects are completed the study.
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: Donepezil Hydrochloride
    Donepezil Hydrochloride Tablets 10 mg
    Other Name: Aricept 10 mg
  • Drug: Aricept
    Aricept 10 mg Tablets
  • Experimental: Donepezil Hydrochloride10 mg Tablets
    Donepezil Hydrochloride 10 mg Tablets of Dr. Reddy's Laboratories Limited
    Intervention: Drug: Donepezil Hydrochloride
  • Active Comparator: Aricept 10 mg Tablets
    Aricept 10 mgTablets of Pfizer Inc
    Intervention: Drug: Aricept
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2009
November 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
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Principal Investigator: Dr. L Krishna Murthy Bioserve Clinical Research Private Limited
Dr. Reddy's Laboratories Limited
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP