Bioequivalence study of FDC Dapagliflozin 10 mg + Linagliptin 05 mg + Metformin Hydrochloride(as extended release) 1000 mg film coated Tablets
- Registration Number
- CTRI/2024/02/062871
- Lead Sponsor
- Optimus Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Volunteers who accept for participating in this study must:
1.Healthy, adult human, subjects aged between 18-45 years (both inclusive) at
the time of screening.
2.Having a Body Mass Index (BMI) between 18.50 to 29.99 kg/m2 (both
inclusive) at the time of screening.
3. Normal or clinically insignificant findings during screening, medical history,
clinical examination including vital signs, laboratory evaluations, 12 lead
ECG and X-ray chest (posterior-anterior view) recordings.
4. Able to comply with the study procedures, in the opinion of the principal
investigator.
5.Compliance with study specific restrictions and prohibitions.
6. Able to give voluntary written informed consent for participation in the trial.
In case of Female subjects:
7. Female subjects who are of child bearing potential and are willing to use a
suitable and effective double barrier contraceptive method or non-hormonal
intra uterine device during the study.
8. Female subjects who are tested negative for serum pregnancy test at the time
of check-in.
9. Female subjects who are tested negative for urine pregnancy test at the time
of screening.
If any subject is having any of the following conditions, then exclude him/her from
participation in this study
1. Known hypersensitivity or idiosyncratic reaction to the study drug or any
related drug.
2. History or presence of any disease or disorder known to influence bone
metabolism, compromise the hemopoietin, renal, hepatic, endocrine,
pulmonary, central nervous, cardiovascular, immunological, dermatological,
gastrointestinal, musculoskeletal or any other body system.
3. Ingestion of any medicine at any time within 14 days prior to IP
administration in period I. In any such case subject selection will be at the
discretion of the principal investigator.
4. Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
5. Smokers and Alcoholics.
History of dehydration from diarrhea, vomiting or any other reason within a
period of 24.00 hours prior to study check-in.
6.An unusual or abnormal diet within 48.00 hours prior to study check-in,
whatever reason e.g. because of fasting due to religious reasons.
7.The presence of clinically significant abnormal laboratory values during
screening.
8.Use of any recreational drugs or history of drug addiction or testing positive
in pre-study urine drug screening and Urine alcohol test.
9. A history of difficulty with donating blood or having donated blood in the
preceding 90 days for males / 120 days for females prior to the start of the
study.
10. Subject who has participated in any other clinical study involving drug
administration and collection of blood samples in the 90 days for males / 120
days for females preceding the start of the study.
11. Difficulty in swallowing capsule/tablet.
12. Positive HIV, VDRL/RPR, Hepatitis B and C tests.
13. Subjects who have used any drugs or substances known to be strong
inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to
IP administration in period I.
14. Pregnant and lactating women or those using hormonal contraceptives
(oral implants).
15. History of undiagnosed vaginal bleeding (for females only).
16.Female subjects who demonstrates a positive pregnancy during screening or
currently breast-feeding.
17.Female volunteer who has used implanted or injected hormonal
contraceptives anytime during the 6 months prior to study or used hormonal
contraceptives within 14 days before dosing.
Prior to check-in of Period- I, complete the Inclusion and Exclusion Criteria
for each volunteer. Only suitable
volunteers should be allowed to participate in the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method inagliptin: Cmax, and AUC (0-72) <br/ ><br>Dapagliflozin and Metformin: Cmax, AUC(0-t) and AUC(0-inf)Timepoint: Total 27 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 5.0 mL will be collected in Ice cold bath at each period. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTA vacutainers. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method inagliptin: Tmax, <br/ ><br>Dapagliflozin & Metformin: Tmax, Kel, t½ & AUCExtrapolated%Timepoint: Total 27 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 5.0 mL will be collected in Ice cold bath at each period. The pre-dose & post-dose blood samples will be collected in pre-labeled K2EDTA vacutainers. <br/ ><br> <br/ ><br>