Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olmesartan Medoxomil · 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 AB | OTHER | 16 subjects assigned to the sequence AB will receive a single 40 mg dose of the test product Olmesartan Medoxomil (1 x 40 mg film-coated tablet), marked as A in the sequence, in Period 1 and a single 40 mg dose of the reference product Olmetec® (1 x 40 mg film-coated tablet), marked as B in the sequence, in period 2. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a minimum of 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence BA | OTHER | 16 subjects assigned to the sequence BA will receive a single 40 mg dose of the reference product Olmetec® (1 x 40 mg film-coated tablet), marked as B in the sequence, in Period 1 and a single 40 mg dose of the test product Olmesartan Medoxomil (1 x 40 mg film-coated tablet), marked as A in the sequence, in period 2. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a minimum of 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Name | Type | Description |
|---|---|---|
| Olmesartan Medoxomil 40 mg | DRUG | Olmesartan Medoxomil is manufactured by Pharmtechnology LLC, Republic of Belarus. Each film-coated tablet contains 40 mg of olmesartan medoxomil. |
| Olmetec® | DRUG | Olmetec® is manufactured by Daiichi Sankyo Europe GmbH, Germany. Each film-coated tablet contains 40 mg of olmesartan medoxomil. |
Inclusion Criteria: 1\. Provision of signed and dated informed consent form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Healthy male or female adult volunteer 4. A female volunteer meeting one of the following criteria: 1. Physi...
Olmesartan Medoxomil is a small molecule drug being studied for bioequivalence, which means it is being tested to compare two different formulations of the drug to see if they produce the same effects in the body. It is currently in Phase 1 clinical development for this purpose.
Olmesartan Medoxomil is being developed by Ligand Pharmaceuticals Incorporated, which is publicly traded under the ticker symbol LGND on the stock market. The company is conducting clinical trials to evaluate the drug's bioequivalence.
Olmesartan Medoxomil is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its bioequivalence.
Olmesartan Medoxomil has one completed clinical trial registered under NCT03951051, which was a Phase 1 bioequivalence study. The trial involved 32 participants and was conducted in Canada under fasting conditions.
Olmesartan Medoxomil is being studied in a bioequivalence trial that compares two different formulations of the drug. The trial, NCT03951051, was designed to evaluate whether these formulations are equivalent after a single oral dose.