Glimepiride BE Study in Healthy Volunteers Under Fasting Condition Clinical Trial
Official title:
Bioequivalence Study of Two Formulations of Glimepiride Tablet in Healthy Subjects
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).
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.
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment