Fasting Comparative Bioavailability Study of 2 Meloxicam 15 mg Tablets in Healthy Volunteers Under Fasting Condition

Summary

The aim of the study was to compare the bioavailability of two formulations of meloxicam given to healthy volunteers and to demonstrate bioequivalence. The test product, Reumoxicam® 15 mg tablets (Farmak PJSC, Ukraine), given in a single dose was compared with a licensed reference product Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece), in a randomized, laboratory-blind, single dose, two periods, crossover study. The secondary objective of the trial was to investigate the safety of both preparations on the basis of safety clinical and laboratory examinations (at the beginning and at the end of the trial) and registration of adverse events and/ or adverse drug reactions.

Timeline

Start

2014-01-29

Primary completion

2014-02-26

Completion

2014-02-26

Drugs

Indications

No indication recorded.