NCT03422575

Bioequivalence Study of 120 mg Etoricoxib Film-coated Tablets

Bioequivalence Study of 120 mg Etoricoxib Film-coated Tablet Produced by PT Dexa Medica in Comparison With the Comparator Drug (Arcoxia® Film-coated Tablet 120 mg, Frosst Iberica S.A., Spain, for Merck Sharp & Dohme (Australia) Pty Limited, Australia, Registered by PT Schering-Plough Indonesia, Tbk.)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study was a randomized, open-label, two-period, two-sequence, cross-over study, conducted to find out whether the etoricoxib 120 mg film-coated tablet produced by PT Dexa Medica (test drug) was bioequivalent to the reference drug (Arcoxia® Film-Coated Tablet 120 mg, PT. Schering-Plough Indonesia Tbk), under fasting condition with a fourteen days wash-out period, involving 26 healthy adult male and female subjects.

Detailed description

This was a randomized, open-label, two-period, two-sequence, cross-over study under fasting condition with a fourteen days wash-out period, involving 26 healthy adult male and female subjects. The participating subjects had an overnight fast and in the next morning were given orally either one film-coated tablet of the test drug or one film-coated tablet of the reference drug with 200 mL of water. Blood samples were drawn immediately before taking the drug (baseline), and at 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours after drug administration, analysed for plasma concentrations of etoricoxib and used to evaluate the pharmacokinetics parameters of the single dose administration. After a fourteen-day washout period, the procedure was repeated using the alternate drug. The plasma concentrations of etoricoxib were determined by using a high pressure liquid chromatography with ultraviolet detection (HPLC-UV) method.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Etoricoxib 120Mg Film-coated Tablet	One tablet of the Test drug was given orally (swallowed with 200 mL of water, without chewing), after an overnight fast, and after fasting (pre-dose) blood-sampling.
DRUG	Arcoxia® 120 mg Film-coated tablet (Frosst Iberica S.A., Spain for Merck Sharp & Dohme (Australia) Pty Limited, Australia, registered by PT. Schering-Plough Indonesia Tbk)	One tablet of the Reference drug was given orally (swallowed with 200 mL of water, without chewing), after an overnight fast, and after fasting (pre-dose) blood-sampling.

Timeline

• Start date: 2015-12-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2018-02-05
• Last updated: 2018-02-05

Locations

1 site across 1 country: Indonesia