A Bioequivalence Study of Dapagliflozin 10mg and Telmisartan 80mg tablet on healthy human volunteers to compare the plasma concentrations between test and marketed products.
- Registration Number
- CTRI/2023/12/060692
- Lead Sponsor
- Eris Lifesciences Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Non-Smoker Male and non-pregnant female human subjects, 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 50 kg
weight.
3. Subjects with normal findings as determined by baseline history, physical examination
and vital sign examination (blood pressure, pulse rate, respiration rate and body
temperature).
4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry,
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 food, fluid and posture 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. Willing to provide written informed consent to participate in the study.
1. Known history of hypersensitivity to Dapagliflozin and Telmisartan or related drugs.
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 IMP.
4. Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract, blood–forming organs, etc.
5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric
diseases.
6. Participation in a clinical drug study or bioequivalence study 90 days prior to Period-I dosing of the present study.
7. Smokers, or those who have smoked within the last six months prior to the start of the study.
8. History of malignancy or other serious diseases.
9. Blood donation 90 days prior to Period-I dosing of the present study.
10. Subjects with positive HIV tests, HBsAg, or Hepatitis-C tests.
11. Found positive in a breath alcohol test.
12. Found positive in a urine test for drug abuse.
13. History of problem in swallowing of tablet/capsule.
14. Any contraindication to blood sampling.
15. Female subjects found positive serum (ß) Beta-hCG (Human Chorionic Gonadotropin)
test.
16. Lactating women (currently breast-feeding).
17. Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
18. Male subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
19. Use of hormonal contraceptives either oral or implants.
20. History of hypoglycemia.
21. History of bladder cancer and genital mycotic infections.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUC(0-t) and AUC(0-8)Timepoint: Total number of blood samples: 25 per period. <br/ ><br>Sampling hrs: Pre dose (collected within 01.00 hour prior to dosing), and at, 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 07.00, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hrs post dose. <br/ ><br>
- Secondary Outcome Measures
Name Time Method AUC% extrapolation, Kel, Tmax and t1/2 <br/ ><br>Timepoint: Total number of blood samples: 25 per period. <br/ ><br>Sampling hrs: Pre-dose (collected within 01.00 hours prior to dosing), and at, 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 07.00, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hrs post dose