Bioequivalence Test of Piroxicam 20 mg Tablets Produced by PT Trifa Raya Laboratories Compared with Feldene® 20 mg Capsules (Piroxicam 20 mg) Produced by Fareva Amboise, France Marketed by Pfizer Holding France, France
Tahapan Penelitian : Complete
Sponsor:
PT Trifa Raya Laboratories
Mitra Pelaksana:
Not Specified
No Registry
INA-1GG43EX
Tanggal Input Registry : 22-11-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 03-09-2024 |
| Outcome Primer | AUC0-t dan Cmax |
| Outcome Skunder | AUC0-inf , Tmax, Half life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Test of Piroxicam 20 mg Tablets Produced by PT Trifa Raya Laboratories Compared with Feldene® 20 mg Capsules (Piroxicam 20 mg) Produced by Fareva Amboise, France Marketed by Pfizer Holding France, France |
| Judul Penelitian Ilmiah | Bioequivalence Study of Piroxicam 20 mg Tablet Produced by PT Trifa Raya Laboratories in Comparison with Feldene® 20 mg (Piroxicam 20 mg) Capsule Produced by Fareva Amboise, France (Marketing Authorization Holder Pfizer Holding France) |
| Jenis Penelitian | Interventional |
| Intervensi | Piroxicam 20 mg Tablet Produced by PT Trifa Raya Laboratories |
| Jumlah Subyek Penelitian | 16 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Willing to sign informed consent, healthy subjects as determined by the medical laboratory test (routine hematology, liver function, renal function, blood glucose, urinalysis), medical history, and physical examination (result that are not in normal range but clinically insignificant by medical doctor justification could be considered healthy), male or female, age between 18-55 years, normal body weight (Body Mass Index= 18-25 kg/m2), blood pressure: systolic 100-129 mmHg, diastolic 60-84 mmHg, pulse rate 60-90 bpmExclusion Criteria: History of allergy or hypersensitivity or contraindication to piroxicam, any major illness in the past 90 days or clinically significant ongoing chronic medical illness, history of drug or alcohol abuse, participation in any clinical trial or blood donation or significant blood loss more than 300 mL within the past 90 days prior study, positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV, pregnant or lactating female (urinary pregnancy test applied to female subjects at screening and before taking the study drug at Period I and II), any medical condition (present or history) which might affect drug kinetics e.g history of gastric surgery, intestinal digestive disorder, smoking more than 10 (ten) cigarettes per day, history of major illness, e.g. heart failure, hepatitis, hypotension, hyperglycemia, hypertension, etc., intake of any drug or food supplements less than 7 days since the start of study, abnormal electrocardiogram (ECG) |
| Administrative Information | |
| Nomor Persetujuan Etik | 34/UN6.KEP/EC/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | PPUB: RG.01.02.321.07.24.02791/UB |
| Contact Person | apt. Eva Sumiyarni, S.Si. |