Bioequivalence Study of 120 mg Etoricoxib Film-coated Tablets

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03422575
• Date of registration: 30/01/2018
• Prospective Registration: No
• Primary sponsor: Dexa Medica Group
• Public title: Bioequivalence Study of 120 mg Etoricoxib Film-coated Tablets
• Scientific title: 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.)
• Date of first enrolment: December 2015
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03422575
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Indonesia

Contacts

• Name: Effi Setiawati, MSc
• Affiliation: Equilab International

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

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)

Drug: Etoricoxib 120Mg Film-coated Tablet

Primary Outcome(s)

AUC(0-t) [Time Frame: 72 hours]

Cmax [Time Frame: 72 hours]

Secondary Outcome(s)

Tmax [Time Frame: 72 hours]

T1/2 [Time Frame: 72 hours]

Secondary ID(s)

369/EQL/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PT. Equilab International