Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fasting Conditions
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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The volunteers were excluded from the study based on the following criteria:
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Sex: male.
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Age: 18 - 45 years. .
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Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
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Healthy and willing to participate in the study.
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Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
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Non-smokers or smoker who smokes less than 10 cigarettes per day
Exclusion Criteria:
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The volunteers were excluded from the study based on the following criteria:
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Clinically relevant abnormalities in the results of the laboratory screening evaluation.
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Clinically significant abnormal ECG or Chest X-ray.
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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.
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Pulse rate less than 50/minute or more than 100/minute.
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Oral temperature less than 95°P or more than 98.6°P.
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Respiratory rate less than 12/minute or more than 20/minute
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History of allergy to the test drug or any drug chemically similar to the drug under investigation.
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History of alcohol or drug abuse
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Positive breath alcohol test
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Recent history of kidney or liver dysfunction.
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History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
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Volunteers suffering from any chronic illness such as arthritis, asthma etc.
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History of heart failure.
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HIV, HCV, HBsAg positive volunteers.
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Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - Cocaine positive volunteers based on urine test.
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Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
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Administration of any study drug in the period 0 to 3 months before entry to the study.
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History of significant blood loss due to any reason, including blood donation in the past 3 months.
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History of pre-existing bleeding disorder.
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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.
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Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bio Evaluation Centre, Torrent Pharmaceuticals Ltd., | Village Bhat, Gandhinagar | Gujarat | India | 382428 |
Sponsors and Collaborators
- Torrent Pharmaceuticals Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PK-07-116