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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Metformin and Rabeprazole; Drug: Metformin and Pantoprazole; Drug: Metformin

• Registration Number: NCT01857609
• Lead Sponsor: Seoul National University Hospital

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 Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-05
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-15
• Last Update Submitted: 2013-05-15
• Study First Posted: 2013-05-20
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metformin and Rabeprazole	Metformin and Rabeprazole	rabeprazole 20mg(D-2)/metformin 750mg+rabeprazole 20mg(D-1)/metformin 500mg+rabeprazole 20mg(D1)
Metformin and Pantoprazole	Metformin and Pantoprazole	pantoprazole 40mg(D-2)/ metformin 750mg + pantoprazole 40mg(D-1)/metformin 500mg + pantoprazole 40mg(D1)
Metformin only	Metformin	metformin 750mg(D-1), metformin 500mg (D1)

Primary Outcome Measures

Name	Time	Method
AUC(area under the plasma concentration-time curve)	Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose	AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2

Secondary Outcome Measures

Name	Time	Method
AUG(total area under the serum concentration-time curve for glucose)	predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test	AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seoul,, Korea, Republic of