Healthy subjects bioequivalence study Sitagliptin
Conditions
Interventions
Experimental Drug,Active Comparator Drug
Sitagliptin Tablet 100 mg,Januvia 100 mg Tablet
Sponsors
Duopharma Biotech Berhad
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 period. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic pre dose, 00.50, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 09.00, 12.00, 16.00, 24.00, 34.00 and 48.00 hours after dosing The Area Under the Curve (AUC) & Maximum concentration (CMAX) percentage will becalculated. The passing range is between 80 - 125% | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety pre-dose, 00.50, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 09.00, 12.00, 16.00, 24.00, 34.00 and 48.00 hours after dosing. To monitor clinical status, adverse events, laboratory investigations and assess relative safetyand tolerance of Azithromycin formulations. | — |
Countries
India
Contacts
Public ContactShahnun Ahmad
Duopharma Innovation Sdn Bhd
Outcome results
None listed