Bioequivalence Study of FDC of Dapagliflozin 10mg and Sitagliptin 100mg Tablets in healthy volunteers
- Registration Number
- CTRI/2022/02/040406
- Lead Sponsor
- Pinnacle Life Science Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy, human subjects (Male) aged between 18 and 45 years (inclusive of both).
2. Male agreeing to use appropriate contraceptive measures like Double Barrier method (condom + diaphragm, condom or diaphragm + spermicidal gel or foam), and should not donate sperm etc. during study and 15 days after completion of study.
3. Subjects with a BMI between 18.50-30.00 kg/m2 (inclusive of both) and body mass not less than 50.00 kg.
4. Subjects in normal health as determined by personal medical history, clinical examination including vital signs and clinically acceptable results of laboratory examinations (including serological tests).
5. Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording.
6. Subjects having a normal or clinically not significant chest X-Ray (P/A view).
7. A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
8. A negative alcohol urine test or alcohol breath test result.
9. Subject able to communicate effectively and provide written informed consent.
10. Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by ethics committee.
11. Subjects that can provide adequate evidence of their identity.
12. Availability of volunteer for the entire study duration.
13. Ability to fast for at least 14.00 hours and consume standard meals.
Known hypersensitivity to Dapagliflozin and Sitagliptin or to related drugs or any component of this medication.
1. Incapable of understanding the informed consent information.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, (estimated CrCl < 60 mL/min, GFR <60 mL/min), gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the study.
4. Recent history of Pancreatitis.
5. History or presence of diabetes mellitus.
History or presence of diabetic ketoacidosis, rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
6. History or presence of alcoholism or drug abuse.
7. History or presence of asthma, urticaria or other allergic reactions.
8. History or presence of gastric and/or duodenal ulceration.
9. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
10. History or presence of cancer.
11. Difficulty with donating blood.
12. Difficulty in swallowing solids like tablets or capsules.
13. Use of any prescribed medication (including herbal remedies and vitamins) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies and vitamins) during one week prior to study initiation and throughout the study.
14.History or presence of significant smoking (more than 09 cigarettes or beedis/day) or could not abstain from smoking during study.
15. Subject consumed tobacco/ tobacco containing products, pan or pan masala, gutkha, masala (containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study.
16. Subject consumed caffeine and/or xanthine-containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) grapefruit and/ or its juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study.
Major illness during the 90 days before screening.
17. Participation in a drug research study within 90 days of screening.
18. Donation of blood within 90 days of screening.
19. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.
20. History or presence of easy bruising or bleeding.
21. Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study.
22. Subject unwilling to employ appropriate contraceptive measures to ensure that his partner will not get pregnant during the study till 15 days after the completion of study.
23. Subject willing to donate sperms during the study till 15 days after the completion of study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PHARMACOKINETIC PARAMETERS BETWEEN THE REFERENCE AND TEST FORMULATION AUC 0-INF, AUC 0-T AND CMAXTimepoint: Baseline blood sample (pre-dose) will be taken. The other timepoints are mentioned below. <br/ ><br>The pre-dose (0.00 hours) will be collected. Post dose samples will be collected at 1.00, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 10.00, 12.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours post dose in each period in each period.
- Secondary Outcome Measures
Name Time Method Monitoring safety and tolerance of the test treatmentTimepoint: 24 hrs