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More info
You can access this
clinical trial
if you have
Pain
and you are
between 18 and 40
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

The objective of this study was to confirm if two formulations of nimesulide tablets are bioequivalent. Test product was Eskaflam® (Nimesulide 100 mg tablets; GlaxoSmithKline) and reference product Mesulid® (Nimesulide 100 mg tablets; Syntex for Productos Roche). The single dosage was one tablet. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 28 healthy volunteers, both genders, adults between 18-40 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Provided treatments

  • Drug: Nimesulide 100 mg tablets
  • Drug: Nimesulide 100 mg tablets

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01745614. The sponsor of the trial is GlaxoSmithKline and it is looking for 28 volunteers for the current phase.
Official trial title:
Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations Containing Nimesulide 100 mg(Eskaflam®, GlaxoSmithKline México, S.A. de C.V. vs. Mesulid®, Producto de Roche, S.A. de C.V.) in Fasting Healthy Volunteers