Bioequivalence Study of 40 mg Rosuvastatin (Nistrol®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Crestor® 40 mg Film Coated Tablets Manufactured by IPR Pharmaceuticals Inc., Puerto Rico for AstraZeneca UK Limited, United Kingdom, Packed and Released by AstraZeneca Pharmaceutical Co. Ltd, China, Imported by PT. AstraZeneca Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
Tanggal Input Registry : 11-07-2025

06-02-2025
cmax, (AUC0-t), (AUC0-∞)
Tmax, t1/2
 
Bioequivalence Study of 40 mg Rosuvastatin (Nistrol®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Crestor® 40 mg Film Coated Tablets Manufactured by IPR Pharmaceuticals Inc., Puerto Rico for AstraZeneca UK Limited, United Kingdom, Packed and Released by AstraZeneca Pharmaceutical Co. Ltd, China, Imported by PT. AstraZeneca Indonesia
Bioequivalence Study of 40 mg Rosuvastatin (Nistrol®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Crestor® 40 mg Film Coated Tablets Manufactured by IPR Pharmaceuticals Inc., Puerto Rico for AstraZeneca UK Limited, United Kingdom, Packed and Released by AstraZeneca Pharmaceutical Co. Ltd, China, Imported by PT. AstraZeneca Indonesia
Interventional
Rosuvastatin (Nistrol®) 40 mg Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories
32
 

Inclusion Criteria:

1. Gave a written informed consent. 2. Healthy subjects, both sexes, age between 18 to 55 years old. 3. Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2). 4. Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm).* 5. Acceptable medical history and physical examination. 6. Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR).* 7. Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine.* 8. Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria).* 9. Normal cardiovascular function was proven by electrocardiogram (ECG) result. 10. Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV). 11. Negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine. 12. Negative result for pregnancy test (will be done for female subjects at screening, before period I and before period II of the study). Note: * The clinical investigator might include a subject having value outside the accepted range, if in his/her opinion, these values were not clinically significant.

Exclusion Criteria:

1. Smoker. If necessary, light smoker (≤5 cigarettes/day) could be accepted. 2. Pregnant women or nursing mother. 3. Had history of hepatic, cardiovascular, gastrointestinal or renal disease. 4. Had active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3x the upper limit of normal (ULN).(1,2) 5. Had history or condition of myopathy or rhabdomyolysis.(1,2) 6. Hypersensitivity to rosuvastatin or similar medication.(1,2) 7. History of alcohol, drug abuse within 12 months prior to screening for this study. 8. Received any other medications within fourteen days prior to the start of the study. 9. Participated in any clinical study within 3 months after the date of completion. 10. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study.
 
KET-713/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
apt. Windy Lusthom, S.Si