None listed
Conditions
Interventions
Intervention1: Test product (T): Dapagliflozin 10 mg + Pioglitazone 15 mg + Metformin Hydrochloride (sustained Release) 1000 mg Tablets
: Subjects will be fast overnight from at least 10.00 hours (h
XIGDUO® XR 10mg/1000mg (Dapagliflozin and Metformin HCl Extended-Release Tablets) Manufactured by AstraZeneca Pharmaceuticals, USA and Marketed by AstraZeneca Pharma India Ltd., Bangalore, India + Re
Pioglit® 15 (Pioglitazone 15 mg Tablet) Manufactured by Sun Pharma Laboratories India Ltd. will be administered as per randomization schedule with 240 mL ± 2 mL of 20% glucose solution in water. Con
Sponsors
Eris Lifesciences Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy human subjects (Male and female), age in the range of 18 - 45 years both inclusive. 2. Body Mass Index between 18.5-30.0 Kg/m2 extremes included with minimum of 48 kg weight. 3. Subjects with normal findings as determined by baseline history, physical examination and vital sign examination. 4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry (including ALT and AST), urinalysis, 12 lead ECG and chest X-ray (if done). 5. Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until the last blood sample collection in each study period and adherence to all study restrictions. 6. No history of significant alcoholism. 7. No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 06 months 8. Non-smokers as evident from the history obtained. 9. Willing to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity to Dapagliflozin, Pioglitazone, Metformin Hydrochloride or related drugs or any of the excipients. 2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days prior to dosing day. 3. Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IP. 4. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc. 5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases. 6. Not eligible as per Online Volunteer Information System (OVIS). 7. Volunteer who have donated blood or experienced loss of blood of up to 150 ml within 30 days or 150 ml to 250 ml within 60 days or more than 250 ml within 90 days (exclude blood loss for screening) prior to first dose of study 8. History of malignancy or other serious diseases. 9. Abnormal liver function test during the screening. 10. Subjects with positive result of HIV tests or HBsAg or Hepatitis-C tests during screening. 11. Found positive in breath alcohol test and/or urine test for drug abuse. 12. History of problems in swallowing of tablet/capsule 13. Any contraindication to blood sampling. 14. History of hypoglycemia. 15. History of bladder cancer and genital mycotic infections 16. Use of hormonal contraceptives either oral or implants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC(0-t) and AUC(0-inf)Timepoint: Total number of blood samples: 25 samples per period. Sampling hrs : Pre dose 00.00 hr. [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 5 mL at 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hrs. Post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, Kel, tÃ?½ and AUCExtrapolated%Timepoint: Total number of blood samples: 25 samples per period. Sampling hrs : Pre dose 00.00 hr. [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 5 mL at 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hrs. Post-dose. | — |
Countries
India
Contacts
Public ContactMr Ganesh Boddu
Eris Lifesciences Limited
Outcome results
None listed