Healthy subjects bioequivalence study generic Sitagliptin HCL
Conditions
Interventions
Experimental Drug,Active Comparator Drug
Sitagliptin HCL Tablet 100 mg,Januvia 100 mg Tablet
Sponsors
Duopharma Biotech Berhad
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. The subject is aged between 18-50 years old 2. The subject is within the limit of his height and weight as defined by the body mass index range (18.5-30 KG/m2) 3. The subject is willing to undergo the necessary pre & post- medical examination set by this study. 4. The results of medical history, physical examinations, vital signs & conducted medical laboratory test are normal 5. The subject is tested negative for hepatitis (B&C) virus and human immunodeficiency virus (HIV) 6. There is no evidence of psychiatric disorder, antagonistic personality and poor motivation, emotional or intellectual problem likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements 7. The subject is able to understand and willing to sign informed consent form 8. For female subjects, negative pregnancy test and the women is using two reliable contraceptive methods 9. The subject has normal cardiovascular system and ECG recording
Exclusion criteria
Exclusion criteria: 1. The subject is a heavy smoker 9more than 10 cigarettes per day) 2. The subject has suffered an acute illness one week before dosing 3. The subject has history of concurrent abuse of alcohol 4. The subject has history of concurrent abuse of illicit drugs 5. The subject has a history of hypersensitivity and or contraindications to the study drug and any related compounds. 6. The subject has been hospitalized within three months before the study or during the study 7. The subject is vegetarian 8. The subject has consumed caffeine or xanthine containing beverages of food stuffs within two days before dosing and until 23 hours after dosing in all study periods. 9. The subjects has taken prescription medication within two weeks or even and over the counter product within one week before dosing in each study period and any time during study 10. The subject has taken grape fruit containing beverages or food stuff within seven days before first dosing and any time during the study 11. The subject has participate in any clinical study within the last 80 days prior to the present study 12. The subject has donated blood within 80 days before first dosing 13. The subject has history or presence of cardiovascular, pulmonary, renal, hepatic, GI, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Before dosing (zero time) and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 6.00, 8.00, 10.00, 12.00, 23.00 & 48.00 hours post dosing The area under curve (AUC) and Maximum concentration (Cmax) will be calculated | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Before dosing (zero time) and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 6.00, 8.00, 10.00, 12.00, 23.00 & 48.00 hours post dosing To monitor the safety of the subjects and tolerability of single dose formulation | — |
Countries
Jordan
Contacts
Public ContactShahnun Ahmad
Duopharma Innovation Sdn Bhd
Outcome results
None listed