Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers
Study Details
Study Description
Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin as co-administered tablets and as a combination tablet.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment period 1
|
Drug: repaglinide
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: metformin
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: repaglinide and metformin combination tablet
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
|
| Experimental: Treatment period 2
|
Drug: repaglinide
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: metformin
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: repaglinide and metformin combination tablet
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
|
| Active Comparator: Treatment period 3
|
Drug: repaglinide
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: metformin
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: repaglinide and metformin combination tablet
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
|
Outcome Measures
Primary Outcome Measures
- Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration []
- Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet []
- Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration []
- NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet []
Secondary Outcome Measures
- Repaglinide AUC after NN4440 (1/500) during fed state []
- Repaglinide Cmax after NN4440 ((1/500) during fed state []
- Change in physical examinations from screening []
- Vital signs []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male and female volunteers (female not pregnant, lactating or breastfeeding)
-
BMI (Body Mass Index) between 19-29 kg/m^2, both inclusive
-
Fasting plasma glucose from 70-115 mg/dl
-
Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
Exclusion Criteria:
-
Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease
-
Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening
-
Positive results on screening for Hepatitis B surface antigen, Hepatitis C antibody and HIV (human immunodeficiency virus) antibody
-
Positive results on the drug abuse/alcohol screen
-
Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product dose administration) and for the duration of the study
-
Subject is currently a smoker (more than one cigarette per day or equivalent)
-
Use of grapefruit or grapefruit juice within 7 days of trial product dose administration
-
Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Austin | Texas | United States | 78744 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- NN4440-1753