Clopidogrel Tablets USP 300 mgBE Fasting Study
- Registration Number
- CTRI/2019/04/018856
- Lead Sponsor
- Polygen Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method