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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: repaglinide Drug: metformin Drug: repaglinide and metformin combination tablet
Phase	Phase 1
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT01489644
First Received	December 8, 2011
Last Updated	December 9, 2011
Last verified	December 2011

Tracking Information[ + expand ][ + ]

First Received Date	December 8, 2011
Last Updated Date	December 9, 2011
Start Date	June 2006
Estimated Primary Completion Date	July 2006
Current Primary Outcome Measures	Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration [Designated as safety issue: No] Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration [Designated as safety issue: No] Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration [Designated as safety issue: No] Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration [Designated as safety issue: No]
Current Secondary Outcome Measures	Repaglinide and metformin tmax (time to maximum) following individual administration fasting state [Designated as safety issue: No] Repaglinide and metformin tmax (time to maximum) following NN4440 administration fasting state [Designated as safety issue: No] Physical examinations [Designated as safety issue: No] Vital signs [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Healthy Volunteers
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
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: repaglinide Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order Drug: metformin Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order Drug: repaglinide and metformin combination tablet Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
Study Arm (s)	Experimental: Treatment period 1 Experimental: Treatment period 2 Experimental: Treatment period 3 Active Comparator: Treatment period 4

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	62
Estimated Completion Date	July 2006
Estimated Primary Completion Date	July 2006
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, 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01489644
Other Study ID Numbers	NN4440-1779
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: William Lyness, Ph.D. Novo Nordisk A/S
Verification Date	December 2011

Locations[ + expand ][ + ]