Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zestril · 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 | 19 subjects assigned to the sequence TR will receive a single 20 mg dose of the test product Lisinopril (1 x 20 mg tablet), marked as T in the sequence, in Period 1 and a single 20 mg dose of the reference product Zestril® (1 x 20 mg tablet), marked as R in the sequence, in period 2. 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 | 19 subjects assigned to the sequence RT will receive a single 20 mg dose of the reference product Zestril® (1 x 20 mg tablet), marked as R in the sequence, in Period 1 and a single 20 mg dose of the test product Lisinopril (1 x 20 mg tablet), marked as T in the sequence, in period 2. 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 |
|---|---|---|
| Lisinopril tablet 20 mg | DRUG | Lisinopril is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 20 mg of lisinopril. |
| Zestril® tablet 20 mg | DRUG | Zestril® is manufactured by Avara Reims Pharmaceutical Services, France. Each tablet contains 20 mg of lisinopril. |
Inclusion Criteria: 1. Healthy caucasian men and women aged between 18 to 45 years 2. Verified diagnosis "healthy" according to the anamnesis data and the results of standard clinical, laboratory and instrumental examination methods, physical examination and anamnestic examination 3. The results of...
Zestril is a small molecule drug being studied for bioequivalence, meaning it is being tested to confirm that a new formulation of lisinopril tablet 20 mg matches an existing product in how it is absorbed by the body. It is not approved for any therapeutic indication and remains investigational in clinical development.
Zestril is being developed by Ligand Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker LGND. The company is conducting clinical research on this drug candidate to evaluate its bioequivalence.
Zestril is in Phase 1 clinical development. A Phase 1 bioequivalence study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation.
Zestril has one completed clinical trial, NCT05061901, a Phase 1 bioequivalence study of two formulations of lisinopril tablet 20 mg in healthy volunteers under fasting conditions. The trial enrolled 38 participants in Russia and has been completed.
Zestril is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial was a bioequivalence study, and no approval status has been established for this drug candidate.
Zestril is a formulation of lisinopril, an ACE inhibitor, being tested for bioequivalence. The clinical trial compares two formulations of lisinopril tablet 20 mg, and Zestril is the drug product under investigation in this study.