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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05642845 | Bioequivalence Study of Two Formulations of Atorvastatin Film-coated Tablets 40 mg in Healthy Volunteers Under Fasting Conditions | PHASE1 | COMPLETED | 50 | — | — | Nov 19, 2022 | Jun 5, 2023 | Jan 11, 2024 | 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 | 25 subjects assigned to the sequence TR will receive a single 40 mg dose of the test product Atorvastatin (1 x 40 mg film-coated tablet), marked as T in the sequence, in Period 1 and Period 3, and a single 40 mg dose of the reference product Liprimar® (1 x 40 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 | 25 subjects assigned to the sequence RT will receive a single 400 mg dose of the reference product Liprimar® (1 x 40 mg tablet), marked as R in the sequence, in Period 1 and Period 3 and a single 40 mg dose of the test product Atorvastatin (1 x 40 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 |
|---|---|---|
| Atorvastatin film-coated tablet 40 mg | DRUG | Atorvastatin is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 40 mg of atorvastatin. |
| Liprimar® film-coated tablet 40 mg | DRUG | Liprimar® is manufactured by Pfizer Pharmaceuticals LLC, Puerto Rico, LLC "Polysan Scientific and Technological Pharmaceutical Firm; RU holder: Pfizer Inc, USA. Each tablet contains 40 mg of atorvastatin. |
Inclusion Criteria: 1. Healthy european men or women aged between 18 to 45 years 2. Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments and imaging studies 3. Body mass index 18.5-30 kg/m² 4. T...