None listed
Conditions
Interventions
Intervention1: Linagliptin 05 mg,Dapagliflozin 10 mg and Metformin Hydrochloride 1000 mg extended release Tablets: After an overnight fasting of at least 10.00 hours, a single dose of FDC of Linaglipt
Sponsors
Optimus Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Linagliptin: Cmax, and AUC (0-72) 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Linagliptin: Tmax, 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. | — |
Countries
India
Contacts
Public ContactDr D Sharmilaa
Notrox research Pvt ltd
Outcome results
None listed