Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PKH-05720-001
Study information
Scientific title
A study to assess the release profiles from fixed combination tablets (gliclazide MR/metformin)
Acronym
Study hypothesis
To compare the release profiles from three fixed combination tablets (gliclazide MR 60 mg metformin) with the free combination and with a 60 mg gliclazide oral solution.
Ethics approval
Ethics approval was obtained before recruitment of the first participants
Study design
Open-label, modified randomised four-way crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes
Intervention
Five periods, single administration: one oral solution of 60 mg gliclazide, three different gliclazide MR 60 mg - metformin fixed tablet combinations and free combination (gliclazide MR 60 mg and metformin) tablets.
Intervention type
Drug
Phase
Phase IV
Drug names
Gliclazide MR, metformin
Primary outcome measures
Determination of the plasma gliclazide and metformin concentration-time data
Secondary outcome measures
1. Adverse events (at all visits)
2. Physical examination (at all visits)
3. 12-lead ECG (at ASSE visit and at the end-of-study visit)
4. Biochemistry and haematology (at ASSE visit, at D1 and at the end-of-study visit)
Overall trial start date
13/09/2010
Overall trial end date
30/11/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy male volunteers between the ages of 18 - 40 years inclusive
2. Normal clinical examination
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12 completed subjects as a minimum
Participant exclusion criteria
Clinically significant abnormality in laboratory screening, including haematology, blood biochemistry and urinalysis
Recruitment start date
13/09/2010
Recruitment end date
30/11/2010
Locations
Countries of recruitment
Australia
Trial participating centre
Nucleus Network
Melbourne
VIC 3004
Australia
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Summary results are published in https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
Intention to publish date
Participant level data
Available on request
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/PKH-05720-001_synopsis_report.pdf
Publication summary