Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule Manufactured by PT. Bernofarm in Comparison with 30 mg Takepron® Delayed-Release Capsule Manufactured by Teva Takeda Pharmaceuticals Co., Ltd., Osaka, Japan.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-K0T77QS
Tanggal Input Registry : 17-10-2023

03-03-2023
Cmax, AUCt
 
Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule Manufactured by PT. Bernofarm in Comparison with 30 mg Takepron® Delayed-Release Capsule Manufactured by Teva Takeda Pharmaceuticals Co., Ltd., Osaka, Japan.
Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule Manufactured by PT. Bernofarm in Comparison with 30 mg Takepron® Delayed-Release Capsule Manufactured by Teva Takeda Pharmaceuticals Co., Ltd., Osaka, Japan.
Interventional
30 mg Lansoprazole delayed-release capsule
27
 

Inclusion Criteria:

Subjects had read the subject information and signed informed consent documents, Subjects healthy male and female, Subjects age range from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had the blood pressure within normal range (systolic 90 - 120 mmHg and diastolic 60 - 80 mmHg), Subjects had the heart rate within normal range (60 – 100 bpm), Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.

Exclusion Criteria:

Those who were pregnant and/or nursing women (for women), Those with history of contraindication or hypersensitivity to lansoprazole, or other proton pump inhibitor drugs or other ingredients in the drugs or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction, Those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, Those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities, Those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day, Those who had participated in any clinical study within 3 months prior to the study (
 
KET-137/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
663/STD/PML/2022
Nabila Mudin Sutanto, Pharm