23.Mar.2016

Bioequivalence study of pain relief drug: clinical part completed

This is a single center, randomized, open label, two-way crossover bioequivalence trial in healthy volunteers for an international pharmaceutical company.

The study was aimed to prove bioequivalence of the investigational drug and the reference drug administered with the similar dosage. Previous clinical studies demonstrated the efficacy of the active ingredient in the relief of acute pain conditions including minor pain of arthritis, muscular aches, backaches, menstrual cramps, headaches, toothaches, etc.

Over 20 healthy men and women aged from 18 to 45 y.o. were randomized into one of the two treatment sequences following the screening procedure. The total duration of volunteers’ participation in the study was 20-22 days. Clinical data processing is underway.

In this clinical trial OCT team was responsible for monitoring and final report preparation. During the last several years, we have successfully completed dozens of bioequivalence studies. Our dedicated professionals can provide you with a turnkey solution: from design development and medical writing to regulatory submission of a final report. Having more than 10 years’ clinical trials experience at the local market, we may guarantee high completion rates for bioequivalence studies.