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.)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Etoricoxib 120Mg Film-coated Tablet; 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)

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 12430
    • PT Equilab International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male and female subjects Healthy was defined as the absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.
2. Aged 18 - 55 years inclusive.
3. Preferably non-smokers or smoke less than 10 cigarettes per day.
4. Able to participate and would provide written informed consent to participate.
5. BMI within 18 to 25 kg/m2.
6. Vital signs (after 10 minutes rest) were within the following ranges:

SBP 100 - 120 mmHg ; DBP 60 - 80 mmHg; HR 60 - 90 bpm.

Exclusion Criteria:

1. Personal/family history of allergy or hypersensitivity or contraindication to etoricoxib or allied drugs.
2. Pregnant or lactating women.
3. Any major illness in the past 90 days or clinically significant ongoing chronic illness
4. Presence of any clinically significant abnormal laboratory values during screening.
5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
6. Clinically significant hematology abnormalities.
7. Clinically significant electrocardiogram (ECG) abnormalities.
8. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery.
9. Past history of anaphylaxis or angioedema.
10. History of drug or alcohol abuse within 12 months prior to screening for this study.
11. Participation in any clinical trial within the past 90 days calculated from the last visit.
12. History of any bleeding or coagulative disorders.
13. History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm.
14. A donation or loss of 300 mL (or more) of blood within 3 months before this study's first dosing day.
15. Intake of any prescription, non-prescription drug, food supplement or herbal medicine within 14 days of this study's first dosing day.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Etoricoxib 120Mg film-coated Tablet at single dose was given to subjects in this arm.	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.; Other Names: Test
Active Comparator: Reference; 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) was given to subjects in this arm.	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.; Other Names: Reference

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0-t)	The area under plasma concentration-time curve from time zero to last observed concentration truncated at 72-hour (AUC0-72h)	72 hours
Cmax	Maximum plasma concentration	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time to maximum plasma concentration	72 hours
T1/2	The terminal half-life	72 hours

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Collaborators: PT. Equilab International
• Investigators: Study Director: Effi Setiawati, MSc, Equilab International

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib
• Other Study ID Numbers: 369/EQL/2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No