Bioequivalence Study of 40 mg Rosuvastatin Film Coated Caplets, Manufactured by PT. Dipa Pharmalab Intersains (Suvesco®) in Comparison with the Innovator’s Film Coated Tablets (Crestor®), Manufactured by IPR Pharmaceuticals Inc., Puerto Rico for AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom, Packed and Released by AstraZeneca Pharmaceutical Co. Ltd. Wuxi, Jiangsu, China, Imported by PT. AstraZeneca Indonesia, Cikarang, Bekasi, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Econolab
No Registry
INA-SZFAXCW
Tanggal Input Registry : 09-02-2024

01-02-2020
AUC-t and Cmax
AUC0-t, Tmax, T1/2
 
Bioequivalence Study of 40 mg Rosuvastatin Film Coated Caplets, Manufactured by PT. Dipa Pharmalab Intersains (Suvesco®) in Comparison with the Innovator’s Film Coated Tablets (Crestor®), Manufactured by IPR Pharmaceuticals Inc., Puerto Rico for AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom, Packed and Released by AstraZeneca Pharmaceutical Co. Ltd. Wuxi, Jiangsu, China, Imported by PT. AstraZeneca Indonesia, Cikarang, Bekasi, Indonesia
Bioequivalence Study of 40 mg Rosuvastatin Film Coated Caplets, Manufactured by PT. Dipa Pharmalab Intersains (Suvesco®) in Comparison with the Innovator’s Film Coated Tablets (Crestor®), Manufactured by IPR Pharmaceuticals Inc., Puerto Rico for AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom, Packed and Released by AstraZeneca Pharmaceutical Co. Ltd. Wuxi, Jiangsu, China, Imported by PT. AstraZeneca Indonesia, Cikarang, Bekasi, Indonesia
Interventional
Single dose of one film coated tablet of 20 mg Rosuvastatin (Suvesco®), Manufactured PT Dipa Pharmalab Intersains
18
 

Inclusion Criteria:

Able to participate, communicate well with the investigators and agree to sign an informed consent; Willing to use contraception (condoms) when intercourse with spouse during the study; Healthy male/female subjects as determined by the medical screening assessments; Aged 18-55 years of age; Body mass index (BMI) is in the range of 18-25 kg/m²; Systolic blood pressure:100-120 mmHg; Diastolic blood pressure: 60-80 mmHg; Pulse rate 60-90 bpm; Normal electrocardiogram (ECG); Clinical laboratory results have to be within normal range. Medical judgement of responsible physician determined any laboratory finding beyond its standard value.

Exclusion Criteria:

Pregnant or lactating women (urinary pregnancy test were applied to female subjects when screening and just before taking the test or innovator drug); Known hypersensitivity or contraindication to the study drug; intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within 7 days of this study’s first dosing day; History of any bleeding or coagulation disorders; Any surgical or medical condition (present or history) which might significantly alters the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery; A donation or loss of 300 mL (or more) of blood within 3 months before this study’s first dosing day; A positive Hepatitis B surface antigen (HBsAg), HCV, HIV test result; History of drug or alcohol abuse within 12 months prior to this study; Heavy Smoker (more than 10 cigarettes a day); Clinically have significant bleeding within 3 months prior to the study; Any myopathy or rhabdomyolisis condition in present or history; Participation in a previous study within 3 months of this study’s first dosing day.
 
KET-47/UN2.F1/ETIK/PPM.00.02/2019
Not applicable
PPUK/PPUB number
PRO-238/19/ECL
Ni Made Dwi Wulandari