None listed
Conditions
Interventions
Intervention1: DS5565 & Metformin: This is a Drug Drug Interaction Study of DS5565 15 mg with Metformin 850 mg, three treatment three period, Period 1 Only DS5565 15 mg, Period 2 Only Metformin 850 mg
Sponsors
Daiichi Sankyo Development Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Males between 18 & 55 years of age, both inclusive 2. BMI of 18.5 to 30.0 kg per meter sq. inclusive 3. Negative urine test for drugs of abuse at screening and on Day -1 of each period 4. Subjects should agree to use a condom and spermicide during sexual intercourse from first dose until 90 days after last dose 5. Negative alcohol test on Day -1 of each period 6. Good Health (physical exam, medical history, lab reports, ECG etc.) 7. Willingness to give written ICF
Exclusion criteria
Exclusion criteria: 1. Clinically relevant abnormality in medical history,physical findings, ECG, or laboratory values that could interfere with the objectives of the study or the safety of the volunteer. 2. Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteerâ??s participation in the study or make participation unnecessarily hazardous. 3. History of impaired hepatic, respiratory, or renal function; history of diabetes mellitus, coronary heart disease, or any psychotic mental illness. 4. History of clinically relevant dizziness or vertigo, or known inner ear problems leading to dizziness or vertigo. 5. History of tremor and any neurological disease. 6. Surgery (eg, stomach bypass) or medical condition that might affect absorption of medicines. 7. Presence or history of severe adverse reaction to any drug (except penicillin) or a history of sensitivity to besylate salts, benzenesulfonic acid, pregabalin (Lyrica®), gabapentin (Neurontin®), or metformin. 8. Blood haemoglobin (Hb) concentration 8.1 mmol/L (13.0 g/dL). 9. Subject smokes more than 10 cigarettes or equivalent per day, and if a smoker, would not be able to abstain from smoking during their period of residence in the Clinical Unit. 10. Use of any prescribed or over-the-counter (OTC) drugs, including vitamins and herbal remedies, in the 2 weeks prior to dose administration (exceptions: paracetamol up to 3 g per day and aspirin up to 1.5 g per day). 11. Concomitant use of medications known to be strong cytochrome P450 (CYP) inducers or inhibitors within 21 days prior to study admission. 12. Consumption of grapefruit, grapefruit juice, pomelos, Seville oranges or St. Johnâ??s wort within 21 days prior to study admission and during confinement. 13. Positive serology for HBsAg, anti-HCV and/or anti-HIV 1 or 2. 14. Loss of more than 450 mL blood during the 3 months before the study (eg, as a blood donor). 15. Participation in another clinical study with investigational drug/device within the 3 months prior to administration of the study drug in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters (CMax, AUC0-48) for DS5565 and metformin dosed alone or co-administered.Timepoint: PK samples for DS-5565 and Metformin will be collected pre-dose on Day 1, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional PK Parameters SafetyTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactPrem Shanker Upadhyay
Ranbaxy Laboratories Limited
Outcome results
None listed