Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.

Overview[ - collapse ][ - ]

Purpose To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose combination of mitiglinide/metformin, compared with free combination of mitiglinide and metformin in healthy male subjects.
ConditionHealthy
InterventionDrug: mitiglinide and metformin
Drug: mitiglinide and metformin
PhasePhase 1
SponsorJW Pharmaceutical
Responsible PartyJW Pharmaceutical
ClinicalTrials.gov IdentifierNCT01443221
First ReceivedSeptember 27, 2011
Last UpdatedSeptember 28, 2011
Last verifiedOctober 2010

Tracking Information[ + expand ][ + ]

First Received DateSeptember 27, 2011
Last Updated DateSeptember 28, 2011
Start DateDecember 2010
Estimated Primary Completion DateJanuary 2011
Current Primary Outcome MeasuresCompare the pharmacokinetic profiles(Cmax, AUClast) of fixed-dose combination versus free dose combination in healthy volunteers [Time Frame: Up to 36 hours postdose for each period] [Designated as safety issue: No]
Current Secondary Outcome MeasuresCompare the pharmacokinetic profiles(tmax, t1/2, AUC0-∞) of fixed-dose combination versus free dose combination in healthy volunteers [Time Frame: Up to 36hours postdose for each period] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitlePharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.
Official TitleOpen-label, Randomized, Single-dose, 2-way Crossover Study to Investigate Safety and Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.
Brief Summary
To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose
combination of mitiglinide/metformin, compared with free combination of mitiglinide and
metformin in healthy male subjects.
Detailed Description
The Korean clinical practice guidelines on DM recommend that a second oral agent with a
different mechanism of action be combined to the regimen when adequate glycemic control is
difficult to achieve with an oral hypoglycemic agent accompanied dietary therapy. Therefore,
a concurrent administration of metformin, a inhibitor of gluconeogenesis, and mitiglinide,
an insulin secretagogue, could be an effective and ideal regimen for management of diabetes.
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
ConditionHealthy
InterventionDrug: mitiglinide and metformin
Free combination of Mitiglinide 10mg and Metformin 500mg
Drug: mitiglinide and metformin
Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg
Study Arm (s)
  • Active Comparator: Free combination
    Free combination of Mitiglinide 10mg and Metformin 500mg
  • Experimental: Fixed-dose combination
    Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment24
Estimated Completion DateJanuary 2011
Estimated Primary Completion DateJanuary 2011
Eligibility Criteria
Inclusion Criteria:

- Healthy males

- Subject with adequate clinical laboratory test results (hematology, blood chemistry,
serology, drug abuse, urinalysis etc.)

- Subject with normal results in blood pressure, pulse, body temperature and ECG test

- Subject with body mass index (BMI) between 18.5 kg/m2 and to 25 kg/m2

Exclusion Criteria:

- Clinically significant functional disorder or acute disease

- Chronic disease affecting the absorption, metabolism or excretion of drug

- Any study drug administration within 90 days before the first drug administration

- Use of medicine affecting drug metabolism (inhibition, induction) such as barbital,
within 30 days before the first drug administration
GenderMale
Ages20 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01443221
Other Study ID NumbersCWP-KAD-05
Has Data Monitoring CommitteeYes
Information Provided ByJW Pharmaceutical
Study SponsorJW Pharmaceutical
CollaboratorsNot Provided
Investigators Principal Investigator: Wooseong Hur, MD, PhD Samsung Medical Center
Verification DateOctober 2010

Locations[ + expand ][ + ]

Samsung Medical Center
Seoul, Korea, Republic of