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

NCT01750931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-07-17

Study results available
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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 Mobic® 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 Mobic® 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

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Meloxicam GSK 15mg

To demonstrate the bioequivalence of Meloxicam 15 mg tablets manufactured by Savipharm J.S.C, Vietnam and Mobic® 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

DRUG

Mobic 15mg

To demonstrate the bioequivalence of Meloxicam 15 mg tablets manufactured by Savipharm J.S.C, Vietnam and Mobic® 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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-12
Primary Completion
2013-10-01
Completion
2013-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01750931 on ClinicalTrials.gov