Bioequivalence study of atorvastatin 20 mg film coated tablet produced by PT Otto Pharmaceutical Industries for PT Pertiwi Agung in comparison with the comparator drug (Lipitor® 20 mg Film Coated Tablet manufactured by Pfizer Pharmaceuticals LLC Vega Baja Puerto Rico, USA; packed and released by Pfizer manufacturing Deutschland GmbH, Germany; imported by PT Pfizer Indonesia) when administered under fasting condition in healthy subjects

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-6DH9H6R
Tanggal Input Registry : 15-02-2023

23-08-2022
The 90% CI of the test/comparator geometric mean ratios for AUC0-t and Cmax
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Bioequivalence study of atorvastatin 20 mg film coated tablet produced by PT Otto Pharmaceutical Industries for PT Pertiwi Agung in comparison with the comparator drug (Lipitor® 20 mg Film Coated Tablet manufactured by Pfizer Pharmaceuticals LLC Vega Baja Puerto Rico, USA; packed and released by Pfizer manufacturing Deutschland GmbH, Germany; imported by PT Pfizer Indonesia) when administered under fasting condition in healthy subjects
Bioequivalence study of atorvastatin 20 mg film coated tablet produced by PT Otto Pharmaceutical Industries for PT Pertiwi Agung in comparison with the comparator drug (Lipitor® 20 mg Film Coated Tablet manufactured by Pfizer Pharmaceuticals LLC Vega Baja Puerto Rico, USA; packed and released by Pfizer manufacturing Deutschland GmbH, Germany; imported by PT Pfizer Indonesia) when administered under fasting condition in healthy subjects
Interventional
The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one film-coated tablet of test drug (atorvastatin 20 mg film coated tablet produced by PT Otto Pharmaceutical Industries for PT Pertiwi Agung) or one film-coated tablet of comparator drug (Lipitor® 20 mg Film Coated Tablet manufactured by Pfizer Pharmaceuticals LLC Vega Baja Puerto Rico, USA; packed and released by Pfizer manufacturing Deutschland GmbH, Germany; imported by PT Pfizer Indonesia)
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Inclusion Criteria:

Able to participate, communicate well with the investigators and would provide written informed consent to participate in the study; Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation; Aged 18 – 55 years inclusive; Non-smokers; Body mass index within 18 to 25 kg/m2; Vital signs (after 10 minutes rest) were within the following ranges: (Systolic blood pressure 100 – 129 mmHg; Diastolic blood pressure 60 – 84 mmHg; Pulse rate 60 – 90 bpm; Respiratory rate 12 – 20 x/minutes; Body temperature < 37.5°C); Willing to practice abstention or non-hormonal contraception during the study.

Exclusion Criteria:

History of allergy or hypersensitivity or contraindication to atorvastatin or allied drugs; Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug); Any major illness in the past 90 days or clinically significant ongoing chronic medical illness; Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc.; Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV; Positive result for COVID-19 rapid antigen test; Clinically significant hematology abnormalities; Clinically significant electrocardiogram (ECG) abnormalities; Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery; Past history of anaphylaxis or angioedema; History of drug or alcohol abuse within 12 months prior to screening for this study; Participation in any clinical trial within the past 90 days calculated from the last visit until this study’s first dosing day; History of any bleeding or coagulative disorders; Presence of difficulty in accessibility of veins in left or right arm; A donation or significant blood loss within 90 days before this study’s first dosing day; Intake of any prescription (especially atorvastatin), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day.
 
No. KET-760/UN2.F1/ETIK/PPM.00.02/2022
BE. 734-C/EQL/2022
Ronal Simanjuntak