Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nimesulide · 1 trial · 1 indication
Pharmacokinetics
Pharmacokinetics
| Arm | Type | Description |
|---|---|---|
| A (reference)/ B (test) | EXPERIMENTAL | initial administration of reference and cross-over to test |
| B (test)/ A (reference) | EXPERIMENTAL | initial administration of test and cross-over to reference |
| Name | Type | Description |
|---|---|---|
| Nimesulide 100 mg tablets | DRUG | Reference product |
Inclusion Criteria: Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice. Healthy, between 18 and 40 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; he...
Nimesulide is a small molecule drug candidate that GSK plc is developing for pain. It is being studied as a treatment in the pain therapeutic area. Nimesulide is also known as Nimesulide 100 mg tablets. It remains in clinical development and is not approved.
Nimesulide is being developed for the treatment of pain. The clinical program has focused on pain as the studied indication. Because it is still in clinical development, its use is limited to research settings and it is not approved for commercial use.
Nimesulide is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this small molecule pain candidate. The company is responsible for its development and any potential regulatory submissions.
Nimesulide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes one completed trial, and there are currently no active trials listed for this candidate.
Nimesulide has been studied in one completed Phase 1 trial, NCT01745614, titled Bioequivalence Study of Nimesulide 100 mg Tablets. The trial enrolled 28 healthy adult volunteers, was randomized and controlled, and included both male and female participants aged 18 years and older.