Clinical Trial to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin

Overview[ - collapse ][ - ]

Purpose This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics and pharmacodynamics of metformin in healthy Korean men.
ConditionHealthy
InterventionDrug: Metformin
Drug: Metformin and Pantoprazole
Drug: Metformin and Rabeprazole
PhasePhase 1
SponsorSeoul National University Hospital
Responsible PartySeoul National University Hospital
ClinicalTrials.gov IdentifierNCT01857609
First ReceivedMay 10, 2013
Last UpdatedMay 15, 2013
Last verifiedMay 2013

Tracking Information[ + expand ][ + ]

First Received DateMay 10, 2013
Last Updated DateMay 15, 2013
Start DateAugust 2012
Estimated Primary Completion DateDecember 2012
Current Primary Outcome MeasuresAUC(area under the plasma concentration-time curve) [Time Frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose] [Designated as safety issue: No]AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2
Current Secondary Outcome MeasuresAUG(total area under the serum concentration-time curve for glucose) [Time Frame: predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test] [Designated as safety issue: No]AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration)

Descriptive Information[ + expand ][ + ]

Brief TitleClinical Trial to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin
Official TitleThe Cross-Over Study to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Korean Men.
Brief Summary
This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics
and pharmacodynamics of metformin in healthy Korean men.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionHealthy
InterventionDrug: Metformin
Other Names:
DiabexDrug: Metformin and Pantoprazole
Other Names:
Diabex, PantolocDrug: Metformin and Rabeprazole
Other Names:
Diabex, Pariet
Study Arm (s)
  • Experimental: Metformin only
    metformin 750mg(D-1), metformin 500mg (D1)
  • Experimental: Metformin and Pantoprazole
    pantoprazole 40mg(D-2)/ metformin 750mg + pantoprazole 40mg(D-1)/metformin 500mg + pantoprazole 40mg(D1)
  • Experimental: Metformin and Rabeprazole
    rabeprazole 20mg(D-2)/metformin 750mg+rabeprazole 20mg(D-1)/metformin 500mg+rabeprazole 20mg(D1)

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment24
Estimated Completion DateDecember 2012
Estimated Primary Completion DateDecember 2012
Eligibility Criteria
Inclusion Criteria:

- healthy male subject aged 20 to 45 at screening

- A body weight in the range of 50 kg (inclusive) - 100 kg (inclusive) with ideal body
weight range of +- 25%

- subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

- subjects who have clinically significant disease of cardiovascular, respiratory,
renal, endocrinological, hematological, gastrointestinal, neurological(central
nervous system), psychiatric disorders or malignant tumor

- Subject judged not eligible for study participation by investigator.
GenderMale
Ages20 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01857609
Other Study ID NumbersMPI
Has Data Monitoring CommitteeNo
Information Provided BySeoul National University Hospital
Study SponsorSeoul National University Hospital
CollaboratorsNot Provided
Investigators Principal Investigator: Jae-Yong Chung, MD, PhD Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea
Verification DateMay 2013

Locations[ + expand ][ + ]

Seoul National University Bundang Hospital
Seoul,, Korea, Republic of