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

This study has been completed.
Sponsor:
Information provided by:
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01419340
First received: August 16, 2011
Last updated: August 17, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Torrent's Donepezil Hydrochloride Tablets 10mg
Phase 1

Study Type: Interventional
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 Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Torrent Pharmaceuticals Limited:

Primary Outcome Measures:
  • 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.


  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01419340

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

No publications provided

Responsible Party: Chief Investigator, Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT01419340     History of Changes
Other Study ID Numbers: PK-07-116
Study First Received: August 16, 2011
Last Updated: August 17, 2011
Health Authority: India: Drugs Controller General of India
India: Indian Council of Medical Research

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 21, 2014