Healthy
Conditions
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
Interventions
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
India
Outcome results
None listed