Bioequivalence Study of 125 mg Ibuprofen Suppository, Manufactured by PT Pharos Indonesia (Proris®) in Comparison with the Reference Suppository (Nurofen® Junior) Manufactured by Famar A. V. E, Greece for Reckitt Benckiser Deutschland GmbH, Germany
Tahapan Penelitian : Complete
Sponsor:
PT Pharos Indonesia
Mitra Pelaksana:
Econolab
No Registry
INA-80KCKWQA
Tanggal Input Registry : 18-12-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 04-11-2024 |
| Outcome Primer | AUC0-t, Cmax |
| Outcome Skunder | AUC0-inf, Tmax, T1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 125 mg Ibuprofen Suppository, Manufactured by PT Pharos Indonesia (Proris®) in Comparison with the Reference Suppository (Nurofen® Junior) Manufactured by Famar A. V. E, Greece for Reckitt Benckiser Deutschland GmbH, Germany |
| Judul Penelitian Ilmiah | Bioequivalence Study of 125 mg Ibuprofen Suppository, Manufactured by PT Pharos Indonesia (Proris®) in Comparison with the Reference Suppository (Nurofen® Junior) Manufactured by Famar A. V. E, Greece for Reckitt Benckiser Deutschland GmbH, Germany |
| Jenis Penelitian | Interventional |
| Intervensi | 125 mg Ibuprofen Suppository (Proris®) manufactured by PT Pharos Indonesia |
| Jumlah Subyek Penelitian | 22 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Able to participate, communicate well with the Investigators and agree to sign the informed consent; Willing to use contraception (condoms) when having intercourse with spouse during the study; Healthy male/female subject, as determined by the medical screening assessments, and does not show any symptoms of Covid-19; Aged 18-55 years; Body mass index (BMI) within the range of 18-25 kg/m²; Have received the complete primary SARS-CoV-2 vaccine and at least the first booster; Normal blood pressure (systolic 100-120 mmHg; diastolic 60-80 mmHg); Normal pulse rate (60-90 bpm); Normal electrocardiogram (ECG); Clinical laboratory results within normal range.Exclusion Criteria: Pregnant or lactating women (urinary pregnancy test was applied to female subjects during screening and just before taking the test or reference product); Hypersensitive (angioedema, rhinitis, bronchospasm, asthma, or urticaria) to the study drug, Acetylsalicylic Acid or other NSAIDs; Contraindicated to the study drug, including severe hepatic failure, severe renal failure, or severe heart failure; Had history of gastrointestinal bleeding or perforation related to previous NSAID treatment, active or history of recurrent peptic ulcer/haemorrhage (two or more episodes of ulceration, hemorrhage, or gastrointestinal disorder); Had colitis, hemorrhoids, anal fissure or any pathological condition of the anus, rectum, or colon; 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 past) 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 300 mL (or more) of blood within 90 days 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 12 months prior to the study; Heavy smoker (more than 10 cigarettes a day); Had a clinically significant bleeding within 90 days prior to the study; Participation in a previous study within 90 days of this study’s first dosing day |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-938/UN2.F1/ETIK/PPM.00.02/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | PRO-275/24/ECL |
| Contact Person | Ni Made Dwi Wulandari |