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OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Oral Bioavailability Study Comparing OXEMET™ 1000 mg Coated Tablets Containing Metformin Hydrochloride With 1000 mg of the Reference Product (GLAFORNIL™) Administered as Two 500 mg Tablets, Through a Randomized, Single-dose, Open Label, Balanced, 2-way Crossover Study in Healthy Volunteers Under Fasting Conditions.OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.

Clinical Trial Summary

This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under fasting conditions, in 24 healthy adult subjects. Each subject will receive two treatments (Treatment A and Treatment B). In Period 1, subjects will be dosed with either one OXEMET™ 1000 mg tablet (Treatment A, Test) or two 500 mg tablets of reference product (GLAFORNIL™ 500 mg) (Treatment B, Reference). Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01842620
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 4
Start date March 13, 2013
Completion date May 4, 2013
View Details
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