Pharmacokinetic and Bioequivalence Study of Generic Sitagliptin Tablet 100 mg (Sitagliptin Phosphate Monohydrate)

Duopharma Biotech Berhad0 个研究点目标入组 27 人开始时间: 2022年6月21日最近更新: 2024年8月19日

适应症

试验速览

The 90% confidence interval of Cmax, AUC0-t and AUC0-inf were within bioequivalence acceptance limit of 80-125%

•1. Subject should be 18 to 55 years of age (both years inclusive)
•2. Capable and willing to give informed written consent and adhere to the study requirements
•3. Subject able to read, write and communicate effectively
•4. BMI between 18.50-30.00 kg/m2 and body weight not less than 50 kg for males and not less than 45 kg in case of females
•6.6. Healthy individuals as evaluated by personal history, medical history and general clinical examination.
•7. Absence of significant disease
•8. Laboratory values or laboratory evaluation within acceptable biological reference range and performed within 21 days prior to Period I check in for the study.
•9. Have a normal 12 lead ECG.
•10. Negative HIV 1 & 2 antibodies, Hepatitis B surface antigen, Hepatitis C antibody and Syphilis.
•11. Negative urine test for drugs of abuse for Morphine, Barbiturates, Benzodiazepines, Amphetamine, Marijuana, THC & cocaine (to be performed on the day of check-in during each period).
•12. Negative Breath alcohol analysis (to be performed on the day of check-in during each period).
•13. Non smoker or smoker of fewer than ten cigarettes per day
•14. Female subjects who are non-pregnant.
•15. Female subjects practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence.

•1. Subjects incapable of understanding the informed consent.
•2. History of any major surgical procedure in the past 3 months.
•3. History of diabetes mellitus, tuberculosis and systemic hypertension.
•4. History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, metabolic, psychiatric, neurological or hematological systems, judged to be clinically significant.
•5. Recent history of dehydration from diarrhoea, vomiting or any other reason within a
•period of 24 hours prior to the study
•6. History of dysphasia.
•7. History of any medical disorder that is of significance in the investigator opinion
•8. Alcohol consumers and found positive in breath alcohol test during check-in of each
•9. History of any drug abuse
•10. History of hypersensitivity to study medications and related drugs e.g., Sulpha drugs,Heparin or excipients in the formulation (if the excipients are known).
•11. History of allergy to vegetables and / or food substances and / or any other manifestations suggestive of hypersensitivity reactions
•12. Present or past history of intake of drugs* which potentially modify kinetics / dynamics of study medications or any other medication judged to be clinically significant by the investigator
•13. Consumption of grapefruit juice and /or grapefruit at least 48-hours prior to Period I check-in to the last PK sample collection of the last Period of the study

发起方

Duopharma Biotech Berhad