Bioequivalence Study of 120 mg Etoricoxib Film-coated Tablets

NCT03422575 | Completed

• 1 other identifier: 369/EQL/2015
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Tmax

  72 hours

• T1/2

  72 hours

Study Arms (2)

Test

EXPERIMENTAL

Etoricoxib 120Mg film-coated Tablet at single dose was given to subjects in this arm.

Drug: Etoricoxib 120Mg Film-coated Tablet

Reference

ACTIVE COMPARATOR

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)

Interventions

Etoricoxib 120Mg Film-coated Tablet DRUG

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.

Also known as: Test

Test

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) DRUG

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.

Also known as: Reference

Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Aged 18 - 55 years inclusive.
• Preferably non-smokers or smoke less than 10 cigarettes per day.
• Able to participate and would provide written informed consent to participate.
• BMI within 18 to 25 kg/m2.
• Vital signs (after 10 minutes rest) were within the following ranges:
• SBP 100 - 120 mmHg ; DBP 60 - 80 mmHg; HR 60 - 90 bpm.

You may not qualify if:

• Personal/family history of allergy or hypersensitivity or contraindication to etoricoxib or allied drugs.
• Pregnant or lactating women.
• Any major illness in the past 90 days or clinically significant ongoing chronic illness
• Presence of any clinically significant abnormal laboratory values during screening.
• Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
• Clinically significant hematology abnormalities.
• Clinically significant electrocardiogram (ECG) abnormalities.
• 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.
• Past history of anaphylaxis or angioedema.
• History of drug or alcohol abuse within 12 months prior to screening for this study.
• Participation in any clinical trial within the past 90 days calculated from the last visit.
• History of any bleeding or coagulative disorders.
• History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm.
• A donation or loss of 300 mL (or more) of blood within 3 months before this study's first dosing day.
• Intake of any prescription, non-prescription drug, food supplement or herbal medicine within 14 days of this study's first dosing day.

Sponsors & Collaborators

• Dexa Medica Group: lead
• PT Equilab International: collaborator

Study Sites (1)

PT Equilab International

Jakarta, 12430, Indonesia

Location

MeSH Terms

Interventions

Etoricoxib

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Effi Setiawati, MSc

  Equilab International

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a bioequivalence study.

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 5, 2018
• Study Start: December 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

ID (1)