Bioequivalence Study of Simvastatin 20 mg Tablets Produced by PT. Kimia Farma Tbk Compared to Zocor 20 mg Tablets Produced by Merck Sharp & Dohme Ltd. United Kingdom
Tahapan Penelitian : Complete
Sponsor:
PT Kimia Farma Tbk
Mitra Pelaksana:
In conducting this research, we collaborated with several partners, there are :
1. Ambulance Gawat Darurat Dinas Kesehatan DKI Jakarta to provide ambulance and paramedical services for emergencies
2. Clinical Laboratory - PT Kimia Farma Diagnostika to carry out medical check-ups
3. Mintohardjo Naval Hospital as a reference for subjects who experienced an adverse event
4. Competent phlebotomist for blood sampling during the study, and
5. Doctor for monitoring vital signs of research subjects
No Registry
INA-S4PZPOG
Tanggal Input Registry : 28-07-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 08-03-2023 |
| Outcome Primer | 1. Maximum plasma concentration (Cmax) [time points : 0 hours (before drug administration); 20 minutes, 40 minutes, and 1; 1.5; 2; 2.5; 3; 4; 5; 6; 8; 10; 12; 16; and 24 hours after drug administration (16 time points) after drug administration] 90% Confidence Interval (80-125) 2. Area Under Curve from 0 to 24 hours (AUCt) [[time points : 0 hours (before drug administration); 20 minutes, 40 minutes, and 1; 1.5; 2; 2.5; 3; 4; 5; 6; 8; 10; 12; 16; and 24 hours after drug administration (16 time points) after drug administration] 90% Confidence Interval (80-125) |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Simvastatin 20 mg Tablets Produced by PT. Kimia Farma Tbk Compared to Zocor 20 mg Tablets Produced by Merck Sharp & Dohme Ltd. United Kingdom |
| Judul Penelitian Ilmiah | Bioequivalence Study of Simvastatin 20 mg Tablets Produced by PT. Kimia Farma Tbk Compared to Zocor 20 mg Tablets Produced by Merck Sharp & Dohme Ltd. United Kingdom |
| Jenis Penelitian | Interventional |
| Intervensi | The reference drug was Zocor® Tablet 20 mg produced by Merck Sharp & Dohme Ltd United Kingdom, batch number W004945, manufacturing date on November 24th 2021, expired date on November 24th 2023. The test drug was Simvastatin 20 mg Tablet produced by PT Kimia Farma Tbk, batch number G20073NX, manufacturing date July 2022, Expired date July 2024. In sampling day, subject took one dose of Simvastatin manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. |
| Jumlah Subyek Penelitian | 33 |
| 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 110-129 mmHg, diastolic blood pressure 70-84 mmHg, normal pulse rate 60-90 bpm, oxygen saturation (SpO2) in the normal range of 95-100%, and normal respiratory rate of 12-20/min.Exclusion Criteria: The exclusion criteria for this study include: 1) Smoking more than 10 cigarettes per day; 2) Pregnant or breastfeeding women. Pregnancy tests was 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 (Simvastatin); 4) Clinically significant hematological 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) Positive rapid antigen test results for SARS-CoV-2 (if the BE study is conducted during a pandemic). 11) History or condition that can affect drug kinetics. 12) Use of drugs or dietary supplements no more than 7 days since the start of the study. 13) Participation in previous clinical trials no more than 3 months from the start of the study. 14) 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-954/UN2.F1/ETIK/PPM.00.02/2022 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | Nungky Tri Yunica, S.T |