Bioequivalence Study of 90 mg Etoricoxib Tablets, Manufactured by PT Lapi Laboratories (Etoricoxib LAPI) in Comparison with The Innovator's Tablets (Arcoxia™) Manufactured by Frosst Iberica, S.A. Via Complutence, 140, Madrid, Spain, Registered and Packed by PT Merck Sharp Dohme Pharma Tbk., Pandaan, Jawa Timur
Tahapan Penelitian : Complete
Sponsor:
PT Lapi Laboratories
Mitra Pelaksana:
Econolab
No Registry
INA-PDA4BAX
Tanggal Input Registry : 27-05-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 02-11-2018 |
| Outcome Primer | AUC0-t, Cmax |
| Outcome Skunder | AUC0-inf, Tmax, T1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 90 mg Etoricoxib Tablets, Manufactured by PT Lapi Laboratories (Etoricoxib LAPI) in Comparison with The Innovator's Tablets (Arcoxia™) Manufactured by Frosst Iberica, S.A. Via Complutence, 140, Madrid, Spain, Registered and Packed by PT Merck Sharp Dohme Pharma Tbk., Pandaan, Jawa Timur |
| Judul Penelitian Ilmiah | Bioequivalence Study of 90 mg Etoricoxib Tablets, Manufactured by PT Lapi Laboratories (Etoricoxib LAPI) in Comparison with The Innovator's Tablets (Arcoxia™) Manufactured by Frosst Iberica, S.A. Via Complutence, 140, Madrid, Spain, Registered and Packed by PT Merck Sharp Dohme Pharma Tbk., Pandaan, Jawa Timur |
| Jenis Penelitian | Interventional |
| Intervensi | Single dose of 90 mg Etoricoxib Tablet (Etoricoxib LAPI) manufactured by PT Lapi Laboratories |
| Jumlah Subyek Penelitian | 14 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Healthy male or female subjects as determined by the medical screening assessments; Aged 18-55 years of age; Body mass index (BMI) is in the range of 18-25 kg/m²; Systolic blood pressure:100-120 mmHg; Diastolic blood pressure: 60-80 mmHg; Pulse rate 60-90 bpm; Normal electrocardiogram (ECG); Able to communicate well with the investigators and agree to sign an informed consent; Clinical laboratory results have to be within normal range.Exclusion Criteria: Pregnant or lactating women (urinary pregnancy test were applied to female subjects when screening and just before taking the test or reference drug); Known hypersensitivity or contraindication to the study drug; Intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within 7 days of this study’s first dosing day; History of any bleeding or coagulation disorders; Any surgical or medical condition (present or history) which might significantly alters the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery; A donation or loss of 450 mL (or more) of blood within 3 months before this study’s first dosing day; A positive Hepatitis B surface antigen (HBsAg), HCV, HIV test result; History of drug or alcohol abuse within twelve (12) months prior to the study; Heavy smoker (more than 10 cigarettes a day); Had clinically significant bleeding within 3 months prior to the study; Participation in a previous study within 3 months of this study’s first dosing day |
| Administrative Information | |
| Nomor Persetujuan Etik | 0118/UN2.F1/ETIK/2018 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | Ni Made Dwi Wulandari |