BIOEQUIVALENCE STUDY OF LANSOPRAZOLE 30 MG DELAYED-RELEASE CAPSULE, LAPROTON® MANUFACTURED BY PT TEMPO SCAN PACIFIC TBK IN COMPARISON WITH LANSOPRAZOLE 30 MG DELAYED-RELEASE CAPSULE, PREVACID® MANUFACTURED BY TAKEDA PHARMACEUTICALS AMERICA INC., USA; ENCAPSULATED AND PACKAGED BY ABBOTT LABORATORIES ARGENTINA S.A., ARGENTINA

Tahapan Penelitian : Recruit
Sponsor:
Mitra Pelaksana:
No Registry
INA-772MFT2
Tanggal Input Registry : 01-09-2023

04-09-2023
to compare the bioequivalency of Lansoprazole 30 mg delayed-release capsule, Laproton® manufactured by PT Tempo Scan Pacific Tbk in comparison with Lansoprazole 30 mg delayed-release capsule, Prevacid® manufactured by Takeda Pharmaceuticals America Inc., USA; encapsulated and packaged by Abbott Laboratories Argentina S.A., Argentina.
 
BIOEQUIVALENCE STUDY OF LANSOPRAZOLE 30 MG DELAYED-RELEASE CAPSULE, LAPROTON® MANUFACTURED BY PT TEMPO SCAN PACIFIC TBK IN COMPARISON WITH LANSOPRAZOLE 30 MG DELAYED-RELEASE CAPSULE, PREVACID® MANUFACTURED BY TAKEDA PHARMACEUTICALS AMERICA INC., USA; ENCAPSULATED AND PACKAGED BY ABBOTT LABORATORIES ARGENTINA S.A., ARGENTINA
BIOEQUIVALENCE STUDY OF LANSOPRAZOLE 30 MG DELAYED-RELEASE CAPSULE, LAPROTON® MANUFACTURED BY PT TEMPO SCAN PACIFIC TBK IN COMPARISON WITH LANSOPRAZOLE 30 MG DELAYED-RELEASE CAPSULE, PREVACID® MANUFACTURED BY TAKEDA PHARMACEUTICALS AMERICA INC., USA; ENCAPSULATED AND PACKAGED BY ABBOTT LABORATORIES ARGENTINA S.A., ARGENTINA
Interventional
Laproton® (Lansoprazole 30 mg Delayed-Release Capsule) manufactured by PT Tempo Scan Pacific Tbk.
36
 

Inclusion Criteria:

Participating subjects will have to fulfill the following inclusion criteria: a. Willing to participate and agree to sign informed consent and communicate well with the investigators; b. Healthy female/male subjects as determined by the medical screening assessments; c. Aged 18 - 55 years inclusive; d. Body mass index within the range of 18.00 - 25.00 kg/m2; e. Vital signs, after 10 minutes resting, within the following ranges: Pulse rate 60 - 90 bpm, respiratory Rate 12 - 20 x/minutes, systolic blood pressure 100 - 129 mmHg, diastolic blood pressure 60 - 84 mmHg, body temperature < 37.5°C; f. Have 12-lead ECG without significant abnormalities; g. Do not have symptoms of Covid-19 and a history of close contact with Covid-19 patients; h. Have received the primary SARS-CoV-2 vaccine complete and at least the first booster;

Exclusion Criteria:

Any of the following criteria will exclude the subject from the study: a. Participate in another study within 3 (three) months prior to the first day of study drug administration; b. Pregnant or lactating female (urinary pregnancy test will be performed on screening day and prior study drug administrations on each period); c. Smoker; d. Intake of any prescription drug or non-prescription drug within 7 days prior to the first day of drug administration of this study; e. Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the first day of study drug administration; f. History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration; g. Known hypersensitivity or contraindication to the study drug; h. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery; i. History of any bleeding or coagulative disorders; j. Clinically significant hematology abnormalities; k. Clinically significant urinalysis abnormalities; l. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL); m. History or presence of any liver dysfunction (SGPT, SGOT, alkaline phosphate, total bilirubin ≥ 1.5 ULN); n. Positive result of HBsAg, HCV, and/or HIV test.
 
No. KET-878/UN2.F1/ETIK/PPM.00.02/2023 dan No. S-501/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Nada Mawaddah