Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers

NCT00959101 | Completed Phase 1

• 1 other identifier: NN4440-1963
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the bioequivalence of repaglinide and metformin combination tablet versus repaglinide and metformin as coadministered tablets after meal. The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic trial where the trial participant is randomised to one of six possible treatment periods (Williams design). The trial participant will receive one single dose of each trial product in varying order.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• AUC0-t and Cmax (after repaglinide 2.0 mg and metformin 500 mg as co-administered tablets and combination tablet dosing under fed state)

  24hr profile after single dose of trial drug in each treatment period

Secondary Outcomes (1)

• Repaglinide AUC(0-24 & 0-∞) and Cmax after combination tablet (repaglinide 1.0 mg/metformin 500 mg) during fed state

  24hr profile after single dose of trial drug in each treatment period

Study Arms (3)

A

EXPERIMENTAL

Drug: repaglinide and metformin combination tablet

B

EXPERIMENTAL

Drug: repaglinide and metformin combination tablet

C

ACTIVE COMPARATOR

Drug: repaglinide; Drug: metformin

Interventions

repaglinide and metformin combination tablet DRUG

Combination tablet of repaglinide (1.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast

A

repaglinide DRUG

Co-administration of metformin 500 mg tablet and repaglinide 2 mg tablet given just prior to a standard normal breakfast

C

metformin DRUG

Concomitant administration: Metformin 500 mg tablet and Repaglinide 2 mg tablet

C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to sign informed consent before initiating any trial related procedures
• BMI: 19.0-25.0 kg/m2
• Fasting plasma glucose: 3.9-6.1 mmol/L
• Trial participant is judged to be in good health on the basis of their medical history, physical examination, ECG, and routine laboratory data

You may not qualify if:

• 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
• Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens that cannot be stopped at least two weeks prior to start of treatment and for the duration of the trial
• 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 (400 mL) within the last 2 months prior to trial product dose administration
• Recent history (within the last 2 years) of drug or alcohol abuse
• Known or suspected allergy to trial product or any of the excipients or a history of multiple and/or severe allergies to drugs or foods or of severe anaphylactic reactions
• Subject has taken an investigational drug in another clinical trial within the last 4 weeks.
• Recent history (within the last 3 month) of nausea, diarrhea or gastrointestinal complaints
• History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose additional risk in administering trial product to the trial participant

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Beijing, Beijing Municipality, 100032, China

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

repaglinide; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 14, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

CN (1)