Bioequivalence Study of 20 mg Rivaroxaban Film Coated Tablets, Manufactured by PT. Lapi Laboratories (Rivaroxaban 20 mg (LAPI)) in Comparison with the Innovator’s Film Coated Tablets (Xarelto®), Manufactured by Bayer Pharma AG, Leverkusen, Germany, Imported by PT. Bayer Indonesia, Depok, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Econolab
No Registry
INA-GZ8CDAB
Tanggal Input Registry : 09-02-2024

22-05-2021
AUC0-t and Cmax
 
Bioequivalence Study of 20 mg Rivaroxaban Film Coated Tablets, Manufactured by PT. Lapi Laboratories (Rivaroxaban 20 mg (LAPI)) in Comparison with the Innovator’s Film Coated Tablets (Xarelto®), Manufactured by Bayer Pharma AG, Leverkusen, Germany, Imported by PT. Bayer Indonesia, Depok, Indonesia
Bioequivalence Study of 20 mg Rivaroxaban Film Coated Tablets, Manufactured by PT. Lapi Laboratories (Rivaroxaban 20 mg (LAPI)) in Comparison with the Innovator’s Film Coated Tablets (Xarelto®), Manufactured by Bayer Pharma AG, Leverkusen, Germany, Imported by PT. Bayer Indonesia, Depok, Indonesia
Interventional
Single dose of one film coated tablet of 20 mg Rivaroxaban (Rivaroxaban 20 mg (LAPI)), Manufactured PT. Lapi Laboratories
22
 

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 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: 70-80 mmHg; Pulse rate 60-90 bpm; Normal electrocardiogram (ECG);

Exclusion Criteria:

Pregnant or lactating women (urinary pregnancy test to be 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; Participation in a previous study within 3 months of this study’s first dosing day; A positive SARS-CoV2 (Covid-19) antigen rapid test result (Covid-19 antigen rapid test to be applied to all subjects when screening and one day before drug administration in each period of study).
 
KET-557/UN2.F1/ETIK/PPM.00.02/2019
Not applicable
PPUK/PPUB number
Ni Made Dwi Wulandari