Bioequivalence study of Prazotec® (Lansoprazole 30 mg) delayed release capsule produced by PT Pratapa Nirmala in comparison with Prevacid® (Lansoprazole 30 mg) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd., Italy, distributed by Takeda Pharmaceuticals America, Inc.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
No Registry
INA-6FT5M32
Tanggal Input Registry : 22-09-2023

20-06-2023
AUC0-t and Cmax
 
Bioequivalence study of Prazotec® (Lansoprazole 30 mg) delayed release capsule produced by PT Pratapa Nirmala in comparison with Prevacid® (Lansoprazole 30 mg) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd., Italy, distributed by Takeda Pharmaceuticals America, Inc.
Bioequivalence study of Prazotec® (Lansoprazole 30 mg) delayed release capsule produced by PT Pratapa Nirmala in comparison with Prevacid® (Lansoprazole 30 mg) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd., Italy, distributed by Takeda Pharmaceuticals America, Inc.
Interventional
The reference drug was Prevacid® (Lansoprazole 30 mg) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd., Italy, distributed by Takeda Pharmaceuticals America, Inc. The test drug was Prazotec® (Lansoprazole 30 mg) delayed release capsule produced by PT Pratapa Nirmala.
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Inclusion Criteria:

Willing to sign the informed consent, Age 18 – 55 years,Body mass index between 18 – 25 kg/m2, Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 60 -80 mmHg),heart rate 60–90 beats per minute, Healthy male (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors'justification on the result of clinical laboratory test include routine hematology, liver function, renal function, random blood glucose and urinalysis; history of disease, and physical examination)

Exclusion Criteria:

Who is contraindicated or had history of hypersensitivity to lansoprazole or related drug With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, Who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (ASL, 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. Clinically significant hematology abnormalities. Who have participated in any clinical study within 3 months prior the study. Who have donated or lost 300 mL (or more) of blood within 3 months prior the study, Who smoke more than 9 sticks of cigarettes a day, Who have any bleeding or coagulation disorder, Who indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV. With the history of alcohol and drug abuse If the study is conducted in Covid-19 pandemic situation, the exclusions criteria bellow must be applied: a. With history of direct contact with a Covid-19 positive person in the subject neighborhood within last 14 days, b. With history or present sore throat, fever (temperature more than 37 o C) or short of breath within last 14 days, c. Positive to Covid-19 antigen rapid test.
 
472/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
apt. Noviyanto, S.Farm