Bioequivalence Study of Clatic XL (Clarithromycin 500 mg) Extended-Release Caplet Produced by PT Imedco Djaja Compared to Abbotic XL (Clarithromycin 500 mg) Extended-Release Tablet Produced by PT Abbott Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT IMEDCO DJAJA
Mitra Pelaksana:
EQuitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-3HS7QY6A
Tanggal Input Registry : 11-08-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 10-06-2025 |
| Outcome Primer | AUC0-t , Cmax |
| Outcome Skunder | AUC0-inf , tmax, half life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Clatic XL (Clarithromycin 500 mg) Extended-Release Caplet Produced by PT Imedco Djaja Compared to Abbotic XL (Clarithromycin 500 mg) Extended-Release Tablet Produced by PT Abbott Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence Study of Clatic XL (Clarithromycin 500 mg) Extended-Release Caplet Produced by PT Imedco Djaja Compared to Abbotic XL (Clarithromycin 500 mg) Extended-Release Tablet Produced by PT Abbott Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Clatic XL (Clarithromycin 500 mg) Extended-Release Caplet Produced by PT Imedco Djaja |
| Jumlah Subyek Penelitian | 32 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: The inclusion criteria for this study include: 1. Signed informed consent; 2. Healthy based on clinical laboratory tests (routine hematology, liver function, kidney function, blood glucose, urinalysis, hepatitis B (HBsAg), hepatitis C (Anti-HCV), and HIV (Anti-HIV), medical history, and physical examination); 3. Male and female subjects (if female, consider the risks for women of childbearing age and perform pregnancy tests); 4. Age between 18-55 years; 5. Normal weight range according to Body Mass Index (BMI) 18-25 kg/m2); 6. Vital signs within the following ranges: systolic blood pressure 100- 129 mmHg, diastolic blood pressure 60-84 mmHg, normal pulse rate 60-90 bpm, oxygen saturation (SpO2) in the normal range of 95- 100%, body temperature 36.5-37.5oC, and normal respiratory rate of 12- 20/minExclusion Criteria: The exclusion criteria for this study include: 1. Smoking more than 10 cigarettes per day; 2. Pregnant or breastfeeding women. Pregnancy tests were performed during screening and prior to the administration of the investigational or comparator drug; 3. History of kidney or liver disease, or history of allergy, hypersensitivity or contraindication to the investigational bioequivalence drug (Clarithromycin); 4. Clinically significant (routine hematology, liver function, kidney function, blood glucose, urinalysis) abnormalities; 5. Abnormal electrocardiogram (ECG); 6. Difficulty accessing veins in the left or right arm; 7. History of significant ongoing clinically or medically significant chronic or acute illness; 8. History of drug or alcohol abuse within the past 12 months (1 year) prior to screening for this study; 9. Positive serology test results for Hepatitis B (HBsAg), Hepatitis C (anti-HCV), HIV (anti-HIV); 10. History or condition that can affect drug kinetics; 11. Use of drugs or dietary supplements no more than 7 days since the start of the study; 12. Participation in previous clinical trials no more than 3 months from the start of the study. The check is conducted using the checksubject.com system based on national identity number; 13. Blood donation or blood loss of more than 300 ml within 3 months from the start of the study |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-581/UN2.F1/ETIK/PPM.00.02/2025 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | Not Specified |
| Contact Person | Bayu Hadi Wahyono, Pharm, B.Pharm, MPH - Study Coordinator (+62 821 2559 0521 - lab.equitrust@gmail.com) |