Recent Updates
Recently added Catalysts

Nimesulide

Phase 1

Pain | Small molecule | Pain |GSK plc|Last Updated: Jun 12, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Nimesulide · 1 trial · 1 indication

Phase 1 1
NCT01745614Bioequivalence Study of Nimesulide 100 mg TabletsPain
COMPLETED28 Analytics
PHASE1COMPLETED
Bioequivalence Study of Nimesulide 100 mg Tablets
Pain
NCT0174561428
Unlock trial analytics

Study Endpoints

Primary Endpoints

Peak Plasma Concentration (CMAX) of nimesulide
0.0, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18.0 and 24.0 postdosage

Pharmacokinetics

Area under the plasma concentration versus time curve (AUC) of nimesulide
0.0, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18.0 and 24.0 postdosage

Pharmacokinetics

Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
A (reference)/ B (test)EXPERIMENTALinitial administration of reference and cross-over to test
B (test)/ A (reference)EXPERIMENTALinitial administration of test and cross-over to reference

Interventions

NameTypeDescription
Nimesulide 100 mg tabletsDRUGReference product
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes

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...

Unlock Eligibility Criteria

Frequently asked questions about Nimesulide

What is Nimesulide used for?

Nimesulide is a small molecule drug being developed for the treatment of pain. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being studied for its potential to manage pain symptoms, though it is not yet approved for this use.

Who makes Nimesulide?

Nimesulide is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research to evaluate the drug's safety and efficacy for pain management.

What phase is Nimesulide in?

Nimesulide is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The drug is being studied in early-stage clinical trials to assess its safety, tolerability, and pharmacokinetic profile in humans.

What clinical trials is Nimesulide in?

Nimesulide has one completed clinical trial registered under NCT01745614, titled "Bioequivalence Study of Nimesulide 100 mg Tablets." This Phase 1 study enrolled 28 participants and evaluated the bioequivalence of the drug. The trial was controlled but not double-blinded.

Is Nimesulide FDA approved?

Nimesulide is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for pain. The drug has completed one early-stage clinical trial, but it has not yet undergone the full regulatory review process required for approval.