None listed
Conditions
Interventions
Intervention1: Test Product: Fixed Dose Combination of Vildagliptin Sustained Release 100 mg, Dapagliflozin 10 mg and Metformin Hydrochloride Sustained Release 1000 mg Tablets (T) Manufactured by Eris
Sponsors
Eris Lifesciences 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 the case of Female subjects: (1) 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. (2) Female subjects who are tested negative for serum pregnancy test at the time of check-in. (3) 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. (6) History of dehydration from diarrhea, vomiting, or any other reason within a period of 24.00 hours prior to study check-in. (7) 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. (8) The presence of clinically significant abnormal laboratory values during screening. (9) Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test. (10) 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. (11) 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. (12) Difficulty in swallowing capsule/tablet. (13) Positive HIV, VDRL/RPR, Hepatitis B and C tests. (14) 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. (15) Pregnant and lactating women or those using hormonal contraceptives (oral/implants). (16) History of undiagnosed vaginal bleeding (for females only). (17) Female subjects who demonstrate a positive pregnancy during screening or currently breast-feeding. (18) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC(0-t) and AUC(0-inf) Timepoint: Total 23 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. The post-dose blood samples of 5.0 mL will be collected in Ice cold bath at 00.33, 00.67, 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, 12.00, 16.00, 20.00, 24.00, 30.00, 36.00, 48.00 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, Kel, t½ and AUCExtrapolated% Timepoint: Total 23 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. | — |
Countries
India
Contacts
Public ContactMr Ganesh Boddu
Eris Lifesciences Ltd
Outcome results
None listed