None listed
Conditions
Interventions
Intervention1: Clopidogrel Tablets USP 300 mg: Clopidogrel Tablets USP 300 mg Manufactured by Polygen Pharmaceuticals Inc
Control Intervention1: PLAVIX® (clopidogrel bisulfate) tablets 300 mg: PLAVIX
Sponsors
Polygen Pharmaceuticals Inc
Eligibility
Inclusion criteria
Inclusion criteria: i. Subjects who are able to understand and provide written informed consent. ii. Subjects must be healthy, adult, human beings within 18-45 years of age (both inclusive) weighing at least 50 kgs. iii. Having a Body Mass Index (BMI) between 18.50 and 24.90 (both inclusive), calculated as weight in Kg/height in m2. iv. Subjects must be of normal health as determined by medical history and physical examination performed within 28 days prior to the dosing (excluding screening day and check-in day) of 1st period. v. Have normal ECG, chest X-ray and vital signs (Oral Temperature-950F to 990F, Pulse rate-60 to 100 per minute, Respiratory rate 14-20 per minute, Systolic blood pressure-90 to 140 mm/Hg and Diastolic blood pressure-60 to 90 mm/Hg). vi. Subjects whose screening laboratory values are within normal limits or laboratory abnormalities considered by the investigator to be of no clinical significance. vii. Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent. viii. If study participant is a female volunteer and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) Or abstinence Or is postmenopausal for at least 1 year or is surgically sterile (bilateral tubal ligation, bilateral Oophorectomy or hysterectomy has been performed on the study participant). ix. Female study participant will be given a negative serum pregnancy test at screening, check-in for all periods and at the time of post-study.
Exclusion criteria
Exclusion criteria: i. History of hypersensitivity or idiosyncratic reaction to Clopidogrel or any other related drugs. ii. Subjects with history or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric diseases. iii. Subjects positive for HIV antibody, HCV and Hepatitis B surface antigen. iv. Subject with any history of active bleeding such as stomach ulcer or bleeding in the brain. v. History of medication or current use of Aspirin. vi. Consumption of grapefruit and its juice for the past 03 days prior to the check-in day until the completion of the study. vii. Subjects who have taken over the counter or prescribed medications within 7 days and enzyme modifying medication or any systemic medication (either prescribed or over-the-counter Including Herbal Preparation) during the last 7 days of study initiation and till completion of study and Monoamine Oxidase inhibitor (MAOI) within 14 days of study initiation and till completion of study. viii. Study participants who have a history of alcohol or substance abuse within the last 1 year. ix. Subjects who are in habit of consuming Ghutka, panmasala, tobacco products. x. History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products. xi. Subject had diarrhea in the last 24 hrs which leads to dehydration. xii. Subjects have abnormal value of bleeding time. xiii. Study participants who have participated in any other clinical investigation using experimental drug or had blood loss of more than 350 mL at single occasion in the past 90 days. xiv. Study participants with positive breath alcohol, positive urine screen for drugs of abuse. xv. Female subjects who are pregnant or planning (women with child bearing potential) to become pregnant during the study. xvi. Female volunteers who are currently breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare the oral bioavailability of Clopidogrel Tablets, USP 300 mg Manufactured by Polygen Pharmaceuticals Inc. with PLAVIX® (clopidogrel bisulfate) tablets, 300 mg Distributed by Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership Bridgewater, NJ 08807 in healthy, adult, human subjects under fasting conditionsTimepoint: 0.00, 0.167, 0.25, 0.33, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00 and 24.00 | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. To evaluate the subject safety and tolerability of the Investigational products.Timepoint: 0.00, 0.167, 0.25, 0.33, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00 and 24.00 | — |
Countries
India
Contacts
Public ContactDr C Gayatri Devi
ActimusBiosciences
Outcome results
None listed