Clinical trial NCT01490658: Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers
Official title: A Randomized, Single-Blind, Three-Period Crossover Study Examining the Single Dose Pharmacokinetics of Concomitantly Administered Repaglinide and Metformin Versus Combination Tablet Dosing (NN4440) in Fed Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-13
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration
measure: Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet
measure: Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration
measure: NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet
Secondary outcomes:
measure: Repaglinide AUC after NN4440 (1/500) during fed state
measure: Repaglinide Cmax after NN4440 ((1/500) during fed state
measure: Change in physical examinations from screening
measure: Vital signs
Other outcomes:
Locations:
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Hoelscher D, Chu PL, Lyness W. Fixed-dose combination tablet of repaglinide and metformin is bioequivalent to concomitantly administered individual tablets of repaglinide and metformin : randomized, single-blind, three-period crossover study in healthy subjects. Clin Drug Investig. 2008;28(9):573-82. doi: 10.2165/00044011-200828090-00004.