BIOEQUIVALENCE STUDY OF ETORICOXIB 120 MG (ECOROXIB® 120) FILM-COATED TABLET MANUFACTURED BY PT DIPA PHARMALAB INTERSAINS IN COMPARISON WITH THE COMPARATOR DRUG (ARCOXIA™ 120 MG FILM-COATED TABLET)
Tahapan Penelitian : Complete
PT Dipa Pharmalab Intersains
PT Equilab International
Tanggal Input Registry : 26-01-2023
|Tanggal Antisipasi Studi
|The 90% CI of the test/comparator geometric mean ratios for AUC0-t and Cmax
|Judul Penelitian Popular
|BIOEQUIVALENCE STUDY OF ETORICOXIB 120 MG (ECOROXIB® 120) FILM-COATED TABLET MANUFACTURED BY PT DIPA PHARMALAB INTERSAINS IN COMPARISON WITH THE COMPARATOR DRUG (ARCOXIA™ 120 MG FILM-COATED TABLET)
|Judul Penelitian Ilmiah
|BIOEQUIVALENCE STUDY OF ETORICOXIB 120 MG (ECOROXIB® 120) FILM-COATED TABLET MANUFACTURED BY PT DIPA PHARMALAB INTERSAINS IN COMPARISON WITH THE COMPARATOR DRUG (ARCOXIA™ 120 MG FILM-COATED TABLET MANUFACTURED BY FROSST IBERICA, S.A., MADRID, SPAIN, REGISTERED AND PACKED BY PT MERCK SHARP DOHME PHARMA TBK, INDONESIA)
|The participating subjects were given orally one test drug (Ecoroxib® 120 mg film-coated tablet manufactured by PT Dipa Pharmalab Intersains) or one comparator drug (Arcoxia™ 120 mg Film-Coated Tablet) after an overnight fast with 200 mL of water.
|Jumlah Subyek Penelitian
Inclusion Criteria:Able to participate, communicate well with the investigators and would provide written informed consent to participate in the study; Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation; Aged 18-55 years inclusive; Preferably non-smokers or smoke less than 10 cigarettes per day; Body mass index within 18 to 25 kg/m2; and Vital signs (after 10 minutes rest) were within the following range: Systolic blood pressure: 100 – 129 mmHg, Diastolic blood pressure: 60 – 84 mmHg, and Pulse rate: 60 – 90 bpm.
Exclusion Criteria:History of allergy or hypersensitivity or contraindication to etoricoxib or allied drug; Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug); Any major illness in the past 90 days or clinically significant on going chronic medical illness; Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc; Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV; Clinically significant hematology abnormalities; Positive result for COVID-19 antigen rapid test; 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 until this study’s first dosing day; History of any bleeding or coagulative disorders; Presence of difficulty in accessibility of veins in left or right arm; A donation or significant blood loss within 90 days before this study’s first dosing day; Intake of any prescription (especially etoricoxib and valdecoxib), non-prescription drug, food supplement or herbal medicine within 21 days of this study’s first dosing day.
|Nomor Persetujuan Etik
|Nomor Persetujuan Material Transfer Agreement
|Nomor Persetujuan Pelaksanaan Uji Klinik
|Other Study ID Numbers