A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Etoricoxib Tablets 120 mg and Reference Product (ARCOXIA 120 mg) in Healthy Thai Volunteers under Fasting Conditions

Phase 1

• Conditions: Healthy, Bioequivalence Study, Thai Volunteers

• Registration Number: TCTR20180925005
• Lead Sponsor: International Bio Service Co.,Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-25
• Study Completion: 2019-01-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1.Healthy Thai male/female subjects between the ages of 18 to 55 years.
2.Body mass index between 18.0 to 30.0 kg/m2.
3.Normal laboratory values, including vital signs and physical examination, for all
parameters in clinical laboratory tests at screening.
4.Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
5.Female subjects abstain from either hormonal methods of contraception (including
oral or transdermal contraceptives, injectable progesterone, progestin subdermal
implants, progesterone-releasing IUDs, postcoital contraceptive methods) or
hormone replacement therapy for at least 28 days prior to admission in Period 1.
Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months
prior to admission in Period 1. Subjects agree to use acceptable non-hormonal
contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for
at least 14 days prior to admission in Period 1 until 7 days after the end of study in
Period 2. Female subjects of non-childbearing potential must meet at least one of the
following criteria prior to admission in Period 1:
ï‚· Postmenopausal for at least 1 year or
ï‚· Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or
hysterectomy) at least 6 months
6.Male subjects who are willing or able to use effective contraceptive e.g. condom or
abstinence after admission in Period 1 until 7 days after the end of study in Period 2
7.Have voluntarily given written informed consent (signed and dated) by the subject
prior to participating in this study.

Exclusion Criteria

1.History of allergic reaction or hypersensitivity to etoricoxib or any of the excipients of the product
2.History or evidence of clinically significant renal, hepatic, gastrointestinal,
hematological (e.g. anemia), endocrine (e.g. thyroid), pulmonary or respiratory,
cardiovascular, psychiatric, neurologic (e.g. convulsion), allergic disease (including
drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of
dosing) or any significant ongoing chronic medical illness
3.History or evidence of active peptic ulceration, gastrointestinal (GI) bleeding or
inflammatory bowel disease
4.History or evidence of asthma, acute rhinitis, nasal polyps, angioneurotic oedema,
asthma, urticaria, or other allergic reactions after taking aspirin or other NSAIDs
5.History or evidence of congestive heart failure, ischaemic heart disease, peripheral
arterial disease or cerebrovascular disease (including persons who have recently
undergone coronary artery bypass graft surgery or angioplasty)
6.History or evidence of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption
7.History of problems with swallowing tablet or capsule
8.History of sensitivity to heparin or heparin-induced thrombocytopenia
9.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy,
gastritis or duodenal or gastric ulceration other than appendectomy
10.History of preceding diarrhea within 24 hours prior to admission in each period
11.History or evidence of drug addict or investigation with urine sample shows a
positive test for drug of abuse (morphine, marijuana or methamphetamine)
12Have sitting systolic blood pressure less than 90 mmHg or more than 139 mmHg or
diastolic blood pressure less than 60 mmHg or more than 89 mmHg at screening or
on the day of admission. If abnormal blood pressure detects, the measurement
should be repeated two more times after take a rest for at least 5 minutes each. The
last measurement value should be used to determine the subject’s eligibility.
1312-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an
abnormality considered clinically significant at screening. If QTc exceeds 450
msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the
average of the three QTc or QRS values will be used to determine the subject’s
eligibility
14.Investigation with blood sample shows positive test for HBsAg
15.Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for
ALT, AST or bilirubin levels at screening laboratory test
16.Have renal creatinine clearance (Clcr) < 30 mL/min based on serum creatinine
results at the screening laboratory test
17.History or evidence of habitual use of tobacco or nicotine containing products and
cannot abstain for at least 7 days prior to admission and continued until last
sample collection in each study period
18.History or evidence of alcoholism, regular alcohol consumption or alcoholcontaining products and cannot abstain for at least 7 days prior to admission and
continued until last sample collection in each study period
19.History or evidence of habitual consume of tea, coffee, xanthine or caffeine
containing products and cannot abstain for at least 7 days prior to admission and
continued until last s

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Etoricoxib plasma concentration 0,0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10 Cmax and truncated AUC 0-72 hrs,Etoricoxib plasma concentration 0,0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10 Cmax and truncated AUC 0-72 hrs,Etoriccoxib plasma conentration 0,0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10 T max,T1/2

Secondary Outcome Measures

Name	Time	Method
Etoricoxib plasma concentration 0,0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10 Tmax T1/2