NCT01677247

Bioequivalence Study of 4 mg Glimepiride Tablet

Bioequivalence Study of Two Formulations of Glimepiride Tablet in Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This was a randomized, single blind, two-period, two sequence cross-over study under fasting condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test and reference formulations).

Detailed description

The participating subjects were required to have an overnight fast; and in the next morning they were given orally either one tablet of 4 mg glimepiride as the test drug (produced by PT Dexa Medica) or one tablet of 4 mg glimepiride (Amaryl®, Sanofi Aventis) as the reference drug with 200 mL water. Blood samples were drawn immediately before taking the drug (control), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 6, 9, 12, 18 and 24 hours after drug administration. Immediately after drug administration, subjects were administered 100 ml of 10% glucose at approximately 0.5, 1.5, 2, 2.5, 3.5, and 4.5 hours. In addition, 20% glucose solution was given to any subject who exhibited symptoms of hypoglycaemia. One week after the first drug administration (wash-out period), the procedure was repeated using the alternate drug. The plasma concentrations of glimepiride were determined by high performance liquid chromatography with ultraviolet detection (HPLC-UV). The pharmacokinetic parameters assessed are AUCt, AUCinf, Cmax, tmax, and t1/2.

Conditions

• Glimepiride BE Study in Healthy Volunteers Under Fasting Condition

Interventions

Type	Name	Description
DRUG	Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica	In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.
DRUG	Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis	In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2012-08-31
• Last updated: 2012-08-31

Locations

1 site across 1 country: Indonesia