Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02502812 | Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects | PHASE1 | COMPLETED | 18 | — | — | Sep 4, 2015 | Sep 24, 2015 | May 8, 2017 | 1 | India |
The following PK parameters were measured: area under the plasma concentration-time curve from time zero to infinity (AUC\[0 ∞\]), area under the plasma concentration-time curve from time zero to last time point with measurable concentration (AUC\[0 t\]) and maximum observed plasma concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence A (Innovator) - B (Clop F1) - C (Clop F2) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 1, 75 mg tablet Clop F1 (Treatment B) in treatment period 2, and 75 mg tablet Clop F2 (Treatment C) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Treatment Sequence A(Innovator) -C(Clop F2)-B (Clop F1) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 1, 75 mg tablet Clop F2 (Treatment C) in treatment period 2, and 75 mg tablet Clop F1 (Treatment B) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Treatment Sequence B (Clop F1) - A (Innovator) - C (Clop F2) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet Clop F1 (Treatment B) in treatment period 1, 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 2, and 75 mg tablet Clop F2 (Treatment C) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Treatment Sequence B (Clop F1) - C (Clop F2) - A (Innovator) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet Clop F1 (Treatment B) in treatment period 1, 75 mg tablet Clop F2 (Treatment C) in treatment period 2, and 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Treatment Sequence C (Clop F2) - A (Innovator) - B (Clop F1) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet Clop F2 (Treatment C) in treatment period 1, 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 2, and 75 mg tablet Clop F1 (Treatment B) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Treatment Sequence C (Clop F2) - B (Clop F1) - A (Innovator) | EXPERIMENTAL | Subjects will receive a single 75 mg tablet Clop F2 (Treatment C) in treatment period 1, 75 mg tablet Clop F1 (Treatment B) in treatment period 2, and 75 mg tablet of reference clopidogrel (Treatment A) in treatment period 3 under fasting conditions. Each treatment period will be separated by 7-14 days of washout Period. |
| Name | Type | Description |
|---|---|---|
| Clop F1 | DRUG | A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state. |
| Clop F2 | DRUG | A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state. |
| Innovator | DRUG | A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state. |
Inclusion Criteria: * Adult subjects aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, la...