Bioequivalence Study of Samcovask® 10 (Amlodipine Besylate 10 mg) Caplet Produced by PT Samco Farma in Comparison with Norvask® (Amlodipine Besylate 10 mg) Tablet Produced by PT Pfizer Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT Samco Farma
Mitra Pelaksana:
Not Specified
No Registry
INA-Q7BGYCC
Tanggal Input Registry : 28-11-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 13-08-2024 |
| Outcome Primer | AUC0-t dan Cmax |
| Outcome Skunder | AUC0-inf , Tmax, Half life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Samcovask® 10 (Amlodipine Besylate 10 mg) Caplet Produced by PT Samco Farma in Comparison with Norvask® (Amlodipine Besylate 10 mg) Tablet Produced by PT Pfizer Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence Study of Samcovask® 10 (Amlodipine Besylate 10 mg) Caplet Produced by PT Samco Farma in Comparison with Norvask® (Amlodipine Besylate 10 mg) Tablet Produced by PT Pfizer Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Samcovask® 10 (Amlodipine Besylate equivalent to Amlodipine 10 mg) Caplet Produced by PT Samco Farma |
| Jumlah Subyek Penelitian | 24 |
| 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 bpm, have received the primary SARS-CoV-2 vaccine complete and at least the first booster or SARS-CoV-2 antigen rapidtest give a nonreactive result.Exclusion Criteria: History of allergy or hypersensitivity or contraindication to amlodipine, 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), liver insufficiency (clinically significant for laboratory testing of SGOT, SGPT, total bilirubin, direct bilirubin > 1.5 ULN), renal insufficiency (clinically significant for laboratory testing of serum creatinine > 1.4 mg/dL), history of close contact with Covid-19 patients within 14 days prior study |
| Administrative Information | |
| Nomor Persetujuan Etik | 736/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.01.02.321.07.24.02755/UB |
| Contact Person | apt. Eva Sumiyarni, S.Si. |