Overview

This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.

Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
It is a randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study of Meloxicam GSK 15 mg tablets manufactured by Savipharm J.S.Cc, Vietnam and MobicĀ® 15 mg tablets of Boehringer Ingelheim Pharma GmbH & Co. KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy, adult, human male subjects under fed condition. It is a pivotal study to demonstrate the bioequivalence of Meloxicam GSK 15 mg tablets manufactured by Savipharm J.S.C, Vietnam and MobicĀ® 15 mg tablets of Boehringer Ingelheim Pharma GmbH & Co.KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy adult human male subjects under fed condition. This study will enroll 28 healthy adult human male subjects
Phase:
N/A
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Meloxicam