Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fed Conditions

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: NCT01419366
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : August 23, 2013
Information provided by:
Torrent Pharmaceuticals Limited

Brief Summary:


To compare the rate and extent of release of the drug substance from the two tablet formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of at least 7 days.

Study Design:

Randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects

Condition or disease Intervention/treatment Phase
Healthy Drug: Torrent's Donepezil Hydrochloride Tablets 10mg Phase 1

Study Type : Interventional  (Clinical Trial)
Official Title: An Open Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Donepezil Hydrochloride Tablets 10mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Aricept® (Donepezil Hydrochloride) Tablets 10mg [Reference Formulation, Eisai Inc.), in Healthy Human Volunteers Under Fed Conditions

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Bioequivalence based on Composite of Pharmacokinetics
    Bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The volunteers were excluded from the study based on the following criteria:

    • Sex: male.
    • Age: 18 - 45 years. .
    • Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
    • Healthy and willing to participate in the study.
    • Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
    • Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

  • The volunteers were excluded from the study based on the following criteria:

    • Clinically relevant abnormalities in the results of the laboratory screening evaluation.
    • Clinically significant abnormal ECG or Chest X-ray.
    • Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
    • Pulse rate less than 50/minute or more than 100/minute.
    • Oral temperature less than 95°P or more than 98.6°P.
    • Respiratory rate less than 12/minute or more than 20/minute
    • History of allergy to the test drug or any drug chemically similar to the drug under investigation.
    • History of alcohol or drug abuse
    • Positive breath alcohol test
    • Recent history of kidney or liver dysfunction.
    • History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
    • Volunteers suffering from any chronic illness such as arthritis, asthma etc.
    • History of heart failure.
    • HIV, HCV, HBsAg positive volunteers.
    • Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
    • Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
    • Administration of any study drug in the period 0 to 3 months before entry to the study.
    • History of significant blood loss due to any reason, including blood donation in the past 3 months.
    • History of pre-existing bleeding disorder.
    • Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
    • Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01419366

Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,
Village Bhat, Gandhinagar, Gujarat, India, 382428
Sponsors and Collaborators
Torrent Pharmaceuticals Limited

Responsible Party: Chief Investigator, Torrent Pharmaceuticals Limited Identifier: NCT01419366     History of Changes
Other Study ID Numbers: PK-07-132
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: August 23, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents