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Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Healthy Volunteers

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2

Intervention: repaglinide (Drug); metformin (Drug); repaglinide and metformin combination tablet (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin administered as an individual tablets with repaglinide and metformin administered as a combination tablet.

Clinical Details

Official title: A Randomized, Single-Blind, Four-Period Crossover Study Examining the Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet Dosing (NN4440) in Fasting and Fed Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome:

Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration

Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration

Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration

Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration

Secondary outcome:

Repaglinide and metformin tmax (time to maximum) following individual administration fasting state

Repaglinide and metformin tmax (time to maximum) following NN4440 administration fasting state

Physical examinations

Vital signs

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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,

health food or dietary supplement regimens, with the exception of contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product 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 administration

- Blood donation, surgery or trauma with significant blood loss (500 mL) within the

last 2 months prior to dosing

Locations and Contacts

Novo Nordisk Clinical Trial Call Center, Tacoma, Washington 98418, United States
Additional Information

Clinical Trials at Novo Nordisk

Starting date: June 2006
Last updated: April 13, 2015

Page last updated: August 23, 2015

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