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.)

NCT03422575 NA COMPLETED

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.

Details

Lead sponsor	Dexa Medica Group
Phase	NA
Status	COMPLETED
Enrolment	26
Start date	2015-12
Completion	2016-03

Conditions

• Healthy

Interventions

• Etoricoxib 120Mg Film-coated Tablet
• 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)

Primary outcomes

• AUC(0-t) — 72 hours
  The area under plasma concentration-time curve from time zero to last observed concentration truncated at 72-hour (AUC0-72h)
• Cmax — 72 hours
  Maximum plasma concentration

Countries

Indonesia