Bioequivalence Study for Donepezil Hydrochloride 10 mg Tablets Under Fasting Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01504503
First received: January 3, 2012
Last updated: January 5, 2012
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Donepezil Hydrochloride
Drug: Aricept
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Area unde 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 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Aricept 10 mg
Active Comparator: Aricept 10 mg Tablets
Aricept 10 mgTablets of Pfizer Inc
Drug: Aricept
Aricept 10 mg Tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504503

Locations
India
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
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01504503     History of Changes
Other Study ID Numbers: 645/09
Study First Received: January 3, 2012
Last Updated: January 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Donepezil
crossover

Additional relevant MeSH terms:
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014