Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Plavix film-coated · 1 trial · 1 indication
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 ...
Plavix film-coated is a small molecule drug being studied for bioequivalence. It is a clopidogrel film-coated tablet at a 75 mg dose, evaluated in healthy male subjects under fasting conditions. The drug is in Phase 1 clinical development.
Plavix film-coated is developed by Ligand Pharmaceuticals Incorporated, a company traded on the stock exchange under the ticker LGND. The drug is currently in Phase 1 clinical development for bioequivalence.
Plavix film-coated is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for bioequivalence in a completed clinical trial.
Plavix film-coated has one completed clinical trial, NCT05934799, titled 'Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting Conditions.' The trial enrolled 60 healthy male subjects in Russia.
Plavix film-coated is a formulation of clopidogrel, as indicated by the clinical trial title. The study compares two formulations of clopidogrel film-coated tablets at a 75 mg dose, suggesting Plavix film-coated is a clopidogrel product.