Bioequivalence Study of Etoricoxib 120 mg Film-Coated Tablets Manufactured by PT. Lloyd Pharma Indonesia (Coxiloid 120 mg) in Comparison with Arcoxia® 120 mg Film-Coated Tablets Manufactured by Rovi Pharma Industrial Services S.A., Spain, registered by PT. Merck Sharp Dohme Pharma Tbk, Indonesia.
Tahapan Penelitian : Complete
Sponsor:
PT. Lloyd Pharma Indonesia
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
Tanggal Input Registry : 16-05-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 25-03-2022 |
| Outcome Primer | 90% Confidence Interval, Cmax and AUCt |
| Outcome Skunder | N.A |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Etoricoxib 120 mg Film-Coated Tablets Manufactured by PT. Lloyd Pharma Indonesia (Coxiloid 120 mg) in Comparison with Arcoxia® 120 mg Film-Coated Tablets Manufactured by Rovi Pharma Industrial Services S.A., Spain, registered by PT. Merck Sharp Dohme Pharma Tbk, Indonesia. |
| Judul Penelitian Ilmiah | Bioequivalence Study of Etoricoxib 120 mg Film-Coated Tablets Manufactured by PT. Lloyd Pharma Indonesia (Coxiloid 120 mg) in Comparison with Arcoxia® 120 mg Film-Coated Tablets Manufactured by Rovi Pharma Industrial Services S.A., Spain, registered by PT. Merck Sharp Dohme Pharma Tbk, Indonesia. |
| Jenis Penelitian | Interventional |
| Intervensi | Subjects were given a single dose of etoricoxib 120 mg of either formulation (test or reference) with 240 mL of water. Subjects were taken the drug products in sitting posture. The tablet was swallowed whole without chewing or crushing. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing |
| Jumlah Subyek Penelitian | 18 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: The inclusion criterias were healthy male or female subjects who/with: - had read the subject information and signed informed consent documents - age range from 18 – 55 years - body mass index between 18 – 25 kg/m2 - had a normal electrocardiogram - had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg) - had the heart rate within normal range (60 – 100 bpm) - had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. - agreed to use protection (condom) before any intercourse with their spouse throughout the studyExclusion Criteria: The subjects’ exclusion criterias for the study were: - those who were pregnant and/or nursing women. - those with history of contraindication or hypersensitivity to etoricoxib, or other NSAIDs, or other ingredients in the study products or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction. - those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease. - those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities. - those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day. - those who had participated in any clinical study within 3 months prior to the study ( |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-1230/UN2.F1/ETIK/PPM.00.02/2021 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 585/STD/PML/2020 |
| Contact Person | Nabila Mudin Sutanto |