Bioequivalence Study of 100 mg Sitagliptin Film-Coated Tablet Manufactured by PT. Hexpharm Jaya in Comparison with 100 mg Januvia® Film-Coated Tablet Manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, Registered and Packed by PT. Merck Sharp Dohme Pharma Tbk, Pandaan, Indonesia

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
Tanggal Input Registry : 08-09-2022

04-12-2020
To investigate whether 100 mg sitagliptin film-coated tablet manufactured by PT. Hexpharm Jaya is bioequivalent to its reference product, 100 mg Januvia® film-coated tablet manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, registered and packed by PT. Merck Sharp Dohme Pharma Tbk, Pandaan, Indonesia.
N.A
 
Bioequivalence Study of 100 mg Sitagliptin Film-Coated Tablet Manufactured by PT. Hexpharm Jaya in Comparison with 100 mg Januvia® Film-Coated Tablet Manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, Registered and Packed by PT. Merck Sharp Dohme Pharma Tbk, Pandaan, Indonesia
Bioequivalence Study of 100 mg Sitagliptin Film-Coated Tablet Manufactured by PT. Hexpharm Jaya in Comparison with 100 mg Januvia® Film-Coated Tablet Manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, Registered and Packed by PT. Merck Sharp Dohme Pharma Tbk, Pandaan, Indonesia
Eksperimental
Subjects were given a single dose of 100 mg sitagliptin film-coated tablet (either test or reference according to randomization code) with 240 mL water.
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Inclusion Criteria:

Inclusion criteria The inclusion criteria are healthy male or female subjects who/with: - have read the subject information and signed the informed consent documents - age 18 – 55 years - body mass index between 18–25 kg/m2 - have a normal electrocardiogram - blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg) - heart rate within normal range (60-100 bpm) - absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

Exclusion criteria Any of the following criteria will exclude the subject from the study: - pregnant and/or nursing woman. - a history of contraindication or hypersensitivity to sitagliptin, other antidiabetic agent or other ingredients in the study products or a history of serious allergic reaction to any drug, significant allergic disease or allergic reaction. - a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction and cardiovascular disease. - a history or presence of any coagulation disorder or clinically significant hematology abnormalities. - 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. - have participated in any clinical study within 3 months prior to the study (< 90 days). - have donated or lost 300 ml (or more) of blood within 3 months prior to the study. - smoker. - those with a history of travelling to another city within the last 14 days - those with a history of direct contact with a COVID-19 positive person in the subject’s neighborhood - those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days - those who are reactive to anti SARS CoV-2 test - positive to HIV, HBsAg, and HCV tests (to be kept confidential). - a history of drug or alcohol abuse within 12 months prior to screening for this study. - unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-870/UN2.F1/ETIK/PPM.00.02/2020
N.A
RG.01.02.321.11.20.00125/UB
526/STD/PML/2020
Nabila Mudin S