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

This study has been completed.
Sponsor:
Information provided by:
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01419366
First received: August 16, 2011
Last updated: August 21, 2013
Last verified: August 2013

August 16, 2011
August 21, 2013
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Bioequivalence based on Composite of Pharmacokinetics [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01419366 on ClinicalTrials.gov Archive Site
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Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fed Conditions
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

Objective:

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

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Interventional
Phase 1
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Healthy
Drug: Torrent's Donepezil Hydrochloride Tablets 10mg
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01419366
PK-07-132
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Chief Investigator, Torrent Pharmaceuticals Limited
Torrent Pharmaceuticals Limited
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Torrent Pharmaceuticals Limited
August 2013

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