Bioequivalence study of atorvastatin 40 mg film coated tablet produced by PT Pratapa Nirmala in comparison with the comparator drug (Lipitor® 40 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-NZAXLYO
Tanggal Input Registry : 30-10-2023

20-03-2023
AUC0-t dan Cmax
 
Bioequivalence study of atorvastatin 40 mg film coated tablet produced by PT Pratapa Nirmala in comparison with the comparator drug (Lipitor® 40 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 40 mg film coated tablet produced by PT Pratapa Nirmala in comparison with the comparator drug (Lipitor® 40 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
one atorvastatin 40 mg film coated tablet of test drug (T) given as a single oral dose with 250 mL of water at ambient temperature after an overnight fast of at least 10 hours
30
 

Inclusion Criteria:

Able to participate, communicate well with the investigators and willing to 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 the 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) must be within the ranges (Systolic blood pressure : 100 – 129 mmHg; Diastolic blood pressure : 60 – 84 mmHg; Pulse rate : 60 – 90 bpm; Respiratory rate : 12-20x / 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 drug; Pregnant or lactating female (urinary pregnancy test will be 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 (this criteria will only be applied if the study conduct during pandemic condition); 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-1324/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
BE. 740/EQL/2022
Ronal Simanjuntak