Bioequivalence study of Etoricoxib 120 mg Film Coated Tablet, Scancox manufactured by PT Tempo Scan Pacific Tbk in comparison with Etoricoxib 120 mg Film Coated Tablet, ArcoxiaTM manufactured by Rovi Pharma Industrial Services S.A., registered and packed by PT Merck Sharp Dohme Pharma Tbk Pasuruan, East Java

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Biometrik Riset Indonesia
No Registry
INA-TK3MF5E
Tanggal Input Registry : 21-11-2022

27-06-2022
Based on the result of the study, it was concluded that the test drug Scancox (BN: 120011) manufactured by PT Tempo Scan Pacific Tbk was bioequivalent in term of both rate and extent of absorption to the reference drug ArcoxiaTM (BN: U011451) manufactured by Rovi Pharma Industrial Services S.A., registered and packed by PT Merck Sharp Dohme Pharma Tbk Pasuruan, East Java
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Bioequivalence study of Etoricoxib 120 mg Film Coated Tablet, Scancox manufactured by PT Tempo Scan Pacific Tbk in comparison with Etoricoxib 120 mg Film Coated Tablet, ArcoxiaTM manufactured by Rovi Pharma Industrial Services S.A., registered and packed by PT Merck Sharp Dohme Pharma Tbk Pasuruan, East Java
Bioequivalence study of Etoricoxib 120 mg Film Coated Tablet, Scancox manufactured by PT Tempo Scan Pacific Tbk in comparison with Etoricoxib 120 mg Film Coated Tablet, ArcoxiaTM manufactured by Rovi Pharma Industrial Services S.A., registered and packed by PT Merck Sharp Dohme Pharma Tbk Pasuruan, East Java
Eksperimental
Subject was given a single dose of Test product, Scancox (Etoricoxib) 120 mg Film Coated Tablet manufactured by PT. Tempo Scan Pacific, or Reference product, ArcoxiaTM (Etoricoxib) 120 mg Film Coated Tablet manufactured by Rovi Pharma Industrial Services S.A., registered and packed by PT Merck Sharp Dohme Pharma Tbk Pasuruan, East Java. Study drug administration was conducted after at least 10 hours overnight fast. Blood sample collection for each period was taken from each subject at certain time intervals post dosing. Study drug administration and blood sample collection were conducted in 2 (two) periods with wash out period of at least seven (7) days.
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Inclusion Criteria:

a.Willing to participate and agree to sign the informed consent and communicate well with the investigators. b.Healthy female/male subjects as determined by the medical screening assessments. c.Aged 18 - 55 years inclusive. d.Body mass index within the range of 18.00 - 25.00 kg/m2. e.Vital signs, after 10 minutes resting, within the following ranges: i.Pulse rate: 60 - 90 bpm. ii.Respiratory rate : 12 – 20 x/minutes. iii.Systolic blood pressure: < 130 mmHg. iv.Diastolic blood pressure: < 85 mmHg. f.Have 12-lead ECG without significant abnormalities. Negative results of rapid test antigen Covid-19 in the screening process.

Exclusion Criteria:

a.Participate in another study within 3 (three) months before the first day of study drug administration. b.Pregnant or lactating female (urinary pregnancy test will be performed on screening day and prior study drug administrations on each period). c.Smoker or smoking more than 10 (ten) cigarettes per day. d.Intake of any prescription drug or non-prescription drug within 7 days before the first day of drug administration of this study. e.Blood donation or blood loss of 300 mL (or more) within 3 (three) months before the first day of study drug administration. f.History of drug and/or alcohol abuse or dependency within 12 months before the first day of study drug administration. g.Known hypersensitivity or contraindication to the study drug. h.Any surgical or medical condition (present or history) that might significantly alter the study's absorption, distribution, metabolism, or excretion, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. i.History of any bleeding or coagulative disorders. j.Clinically significant hematology abnormalities. k.Clinically significant urinalysis abnormalities. l.Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). m.History or presence of any liver dysfunction (SGPT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). n.Positive result of HBsAg, HCV, and/or HIV test.
 
KET-432/UN2.F1/ETIK/PPM.00.02/2022
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RG.01.02.321.06.22.00949/UB
033/BE/FEB-2022 Version 1.00
Oktaviani Utami Dewi