HealthyNCT03422575
Bioequivalence Study of 120 mg Etoricoxib Film-coated Tablets
A study testing Etoricoxib 120Mg Film-coated Tablet and 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) in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Etoricoxib 120Mg Film-coated Tablet and 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)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndonesia
- Study dates
- Dec 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.)
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.
Read the 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
- Being tested
- 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etoricoxib 120Mg Film-coated TabletDrug
Also called Test
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.
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
Also called Reference
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.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Etoricoxib 120Mg film-coated Tablet at single dose was given to subjects in this arm. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-t)
The area under plasma concentration-time curve from time zero to last observed concentration truncated at 72-hour (AUC0-72h)
Measured: 72 hours
Cmax
Maximum plasma concentration
Measured: 72 hours
Secondary outcomes (2)
Tmax
Time to maximum plasma concentration
Measured: 72 hours
T1/2
The terminal half-life
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startDec 2015
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This was a bioequivalence study.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT Equilab International
- Responsible party
- Sponsor
- Investigators
- Effi Setiawati, MSc, Study director, Equilab International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422575
- Sponsor's protocol ID
- 369/EQL/2015
- Status last verified
- Jan 2018
- First submitted
- 30 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.)
- ClinicalTrials.gov ID
- NCT03422575
- Acronym / sponsor ID
- 369/EQL/2015
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Collaborators
- PT Equilab International
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a bioequivalence study.
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Etoricoxib 120Mg Film-coated TabletEtoricoxib 120Mg film-coated Tablet at single dose was given to subjects in this arm. |
| Reference | Active comparator | 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)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etoricoxib 120Mg Film-coated TabletAlso: TestOne 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 | 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)Also: ReferenceOne 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. | Drug | Reference |
Primary outcome
AUC(0-t)
Time frame: 72 hours
The area under plasma concentration-time curve from time zero to last observed concentration truncated at 72-hour (AUC0-72h)
Cmax
Time frame: 72 hours
Maximum plasma concentration
2 secondary outcomes
Tmax
Time frame: 72 hours
T1/2
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Effi Setiawati, MSc study director
Equilab International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etoricoxib 120Mg Film-coated Tablet and 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) in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC(0-t) (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.