Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Liprimar 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 | 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...
Liprimar film-coated is an investigational small molecule being studied for bioequivalence. It is a formulation of atorvastatin film-coated tablets, intended to demonstrate that it is equivalent to a reference product. The drug is currently in Phase 1 clinical development.
Liprimar film-coated is being developed by Ligand Pharmaceuticals Incorporated, a company traded on the NASDAQ under the ticker LGND. The drug is currently in Phase 1 clinical development for bioequivalence.
Liprimar film-coated is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A single Phase 1 bioequivalence study has been completed, and the drug remains in early-stage clinical testing.
Liprimar film-coated has one completed clinical trial, NCT05642845, a Phase 1 bioequivalence study of two formulations of atorvastatin film-coated tablets 40 mg in healthy volunteers under fasting conditions. The trial enrolled 50 participants in Russia and was completed.
Liprimar film-coated is a formulation of atorvastatin, a statin medication. The drug is being studied as a film-coated tablet for bioequivalence, meaning it is intended to match the performance of a reference atorvastatin product. It is currently in Phase 1 development.