Bioequivalence Study of Pantoprazole 40 mg Enteric Coated Tablets Manufactured by PT Kimia Farma in Comparison with Pantoprazole 40 mg, Pantozol® Gastro Resistant Tablets Manufactured by Takeda GmbH – Germany, Registered by PT Takeda – Indonesia.

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
Tanggal Input Registry : 04-01-2023

06-06-2022
To investigate the Bioequivalence Study of Pantoprazole 40 mg Enteric Coated Tablets manufactured by PT Kimia Farma in comparison with Pantoprazole 40 mg, Pantozol® Gastro Resistant Tablet manufactured by Takeda GmbH – Germany, Registered by PT Takeda – Indonesia.
To investigate the Bioequivalence Study of Pantoprazole 40 mg Enteric Coated Tablets manufactured by PT Kimia Farma in comparison with Pantoprazole 40 mg, Pantozol® Gastro Resistant Tablet manufactured by Takeda GmbH – Germany, Registered by PT Takeda – Indonesia.
 
Bioequivalence Study of Pantoprazole 40 mg Enteric Coated Tablets Manufactured by PT Kimia Farma in Comparison with Pantoprazole 40 mg, Pantozol® Gastro Resistant Tablets Manufactured by Takeda GmbH – Germany, Registered by PT Takeda – Indonesia.
Bioequivalence Study of Pantoprazole 40 mg Enteric Coated Tablets Manufactured by PT Kimia Farma in Comparison with Pantoprazole 40 mg, Pantozol® Gastro Resistant Tablets Manufactured by Takeda GmbH – Germany, Registered by PT Takeda – Indonesia.
Eksperimental
An Open label, randomized, three-periods, three treatments, three way partial replicate in fasting condition.
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Inclusion Criteria:

Willing to participate and agree to sign informed consent, and be able to communicate well with the investigators. Healthy female/male subjects as determined by the medical screening assessments. Aged 18 - 55 years inclusive. Body mass index within the range of 18.00 - 25.00 kg/m2. 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. Have 12-lead ECG without significant abnormalities. Negative results of rapid test antigen Covid 19 in screening process.

Exclusion Criteria:

Participate in another study within 3 (three) months prior to the first day of study drug administration. Pregnant or lactating female (urinary pregnancy test will be performed at screening day and prior to study drug administrations on each period). Smoker or smoking more than 10 (ten) cigarettes per day. Intake of any prescription drug or non-prescription drug within 7 days prior the first day of drug administration of this study. Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the first day of study drug administration. History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration. Known hypersensitivity or contraindication to the study drug. 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. History of any bleeding or coagulative disorders. Clinically significant hematology abnormalities. Clinically significant urinalysis abnormalities. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). History or presence of any liver dysfunction (SGPT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). Positive result of HBsAg, HCV, and/or HIV test.
 
KET-56/UN2.F1/ETIK/PPM.00.02/2022 ; KET-56/UN2.F1/ETIK/PPM.00.02/2022
RG.01.02.321.05.22.00898/UB
116/BE/NOV-2021
apt. Dra. Astrid Tiarani Pohan