None listed
Conditions
Interventions
Intervention1: AT -10 (2-Oxo Clopidogrel): AT -10 40mg OD on Day 1
AT -10 10 mg OD on Days, 2, 3, 4, 5 &
6
Control Intervention1: Clopidogrel: Clopidogrel 300 mg OD on Day 1
Clopidogrel 75 mg OD on Da
Sponsors
Ipca Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subjects who are willing to provide voluntary informed consent and are willing to participate in the study. 2) Normal healthy human adult male and/or female subjects between 18-45 years (both ages inclusive) of age. 3) Body Mass Index of 18.50 to 29.90 kg/m2 (both inclusive). 4) No evidence of underlying disease during the pre-study screening, medical history, clinical examination and laboratory investigations performed within 28 days prior to commencement of the study. 5) Subject classified as extensive (normal) metabolizer or poor metabolizer based on CYP2C19 allele 1, 2, 3 and 17 genotyping. 6) Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to participation in the study. 7) Negative test results for alcohol, drugs of abuse, Beta hCG test (for female subjects only) and who is negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR at the time of screening. 8) 12-lead ECG recording within normal or within acceptable limits or as considered by the Investigator to be of no clinical significance with respect to his/her participation in the study.
Exclusion criteria
Exclusion criteria: 1) Known allergic to Clopidogrel, AT-10 or any component of the formulation and to any other related class of drug. 2) History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 3) Female subjects who are nursing motherslactating women. 4) History/presence of significant alcohol dependence (abuse) or drug abuse within the past 1 year. 5) History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products. 6) History/presence of significant Asthma, urticaria or other allergic type reactions after taking any medication. 7) History/presence of clinically significant illness within 04 weeks before the start of the study. 8) History/presence of significant Hypersensitivity to heparin. 9) History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs. 9) Platelet count outside the normal range at screening or housing for Period 1 10) Subjects scheduled for surgery any time during study or within 07 days after study completion. 11) Subjects who have taken prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing of IP, including topical medication. 12) Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication (e.g. Omeprazole or other proton pump inhibitors).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability of AT-10 compared to Clopidogrel administered orally to humans. effect of AT -10 (loading and maintenance doses) Vs the approved doses of Clopidogrel (loading and maintenance doses) on platelet aggregation in poor and extensive metabolizers. Timepoint: 6 days | — |
Secondary
| Measure | Time frame |
|---|---|
| single and multiple dose pharmacokinetics (PK) of Clopidogrel, AT -10, and active metabolite MP-H4Timepoint: 6 days | — |
Countries
India
Contacts
Public ContactNitin Chandurkar
Ipca Laboratories Limited
Outcome results
None listed