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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05934799 | Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting Conditions | PHASE1 | COMPLETED | 60 | — | — | Jun 16, 2023 | Oct 10, 2023 | Nov 30, 2023 | 1 | Russia |
Maximum observed concentration in plasma.
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
| Arm | Type | Description |
|---|---|---|
| Sequence TR | OTHER | 30 subjects assigned to the sequence TR will receive a single 75 mg dose of the test product Clopidogrel (1 x 75 mg film-coated tablet), marked as T in the sequence, in Period 1 and Period 3, and a single 75 mg dose of the reference product Plavix® (1 x 75 mg film-coated tablet), marked as R in the sequence, in period 2 and Period 4. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence RT | OTHER | 30 subjects assigned to the sequence RT will receive a single 75 mg dose of the reference product Plavix® (1 x 75 mg tablet), marked as R in the sequence, in Period 1 and Period 3 and a single 75 mg dose of the test product Clopidogrel (1 x 75 mg tablet), marked as T in the sequence, in period 2 and Period 4. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Name | Type | Description |
|---|---|---|
| Clopidogrel film-coated tablet 75 mg | DRUG | Clopidogrel is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 75 mg of clopidogrel. |
| Plavix® film-coated tablet 75 mg | DRUG | Plavix® is manufactured by Sanofi Winthrop Industry, France; holder RU: Sanofi-Aventis Group S.A., France. Each tablet contains 75 mg of clopidogrel. |
Inclusion Criteria: 1. Healthy european men aged between 18 to 45 years 2. signed informed consent 3. Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments and imaging studies 4. Body mass index ...