Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aceclofenac 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 using the linear trapezoidal method.
| Arm | Type | Description |
|---|---|---|
| Sequence TR | OTHER | 18 subjects assigned to the sequence TR will receive a single 100 mg dose of the test product Aceclofenac (1 x 100 mg tablet), marked as T in the sequence, in Period 1 and a single 100 mg dose of the reference product Airtal ® (1 x 100 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 | 18 subjects assigned to the sequence RT will receive a single 100 mg dose of the test product Airtal ® (1 x 100 mg tablet), marked as R in the sequence, in Period 1 and a single 100 mg dose of thetest product Aceclofenac (1 x 100 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 |
|---|---|---|
| Aceclofenac film-coated tablet 100 mg | DRUG | Aceclofenac is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 100 mg of aceclofenac. |
| Airtal® film-coated tablet 100 mg | DRUG | Airtal ® is manufactured by Gedeon Richter- RUS", Russia / Gedeon Richter, Hungary. Each tablet contains 100 mg of aceclofenac. |
Inclusion Criteria: 1. Healthy european men or women aged between 18 to 45 years 2. The written consent of the volunteer to be included in the study 3. Verified diagnosis "healthy" according to the anamnesis data and the results of standard clinical, laboratory and instrumental examination methods,...
Aceclofenac film-coated is a small molecule drug being studied for bioequivalence, meaning it is evaluated to confirm that a new formulation of aceclofenac 100 mg tablets matches an existing reference product in how it is absorbed and behaves in the body. It is intended for use in healthy volunteers under fasting conditions.
Aceclofenac 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 a bioequivalence study.
Aceclofenac film-coated is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in a single completed Phase 1 bioequivalence trial. The study enrolled 36 healthy volunteers and was conducted in Russia.
Aceclofenac film-coated has one completed clinical trial, registered as NCT05339373, titled "Bioequivalence Study of Two Formulations of Tablets Aceclofenac 100 mg in Healthy Volunteers Under Fasting Conditions." This Phase 1 study enrolled 36 participants, was randomized and controlled, and took place in Russia.
Aceclofenac film-coated is a formulation of aceclofenac, a nonsteroidal anti-inflammatory drug. The film-coated version refers to the tablet coating, and the study compares two formulations of aceclofenac 100 mg tablets to assess their bioequivalence. No other alternative names are provided.