Effect of Omeprazole on Metformin

NCT01711320 | Completed Phase 1 DMC

• 1 other identifier: 20120925XJYYYJK
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, investigators hypothesized that the plasma concentration of metformin and its glucose-lowering action would be affected by omeprazole, probably by altering the expression or function of OCTs in the liver, its primary target organ, as well as in the kidney.

Conditions

Healthy

Keywords

Omeprazole; Metformin

Outcome Measures

Primary Outcomes (1)

• Whether the pharmacokinetics of metformin would be effected by omeprazole

  Pharmacokinetic parameters such as the area under the concentration-time curve (AUC), the elimination half-life(t½) and maximum metformin concentration (Cmax)

  24 weeks

Secondary Outcomes (1)

• Whether the pharmacodynamics of metformin would be effected by omeprazole

  24 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

oral dose of Placebo combined with two dose of Metformin (OGTTs)

Drug: Placebo

Omeprazole

EXPERIMENTAL

oral dose of Omeprazole (80 mg) combined with two dose of Metformin (OGTTs)

Drug: Omeprazole

Interventions

Placebo DRUG

Placebo

Omeprazole DRUG

Also known as: PPI

Omeprazole

Eligibility Criteria

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

You may qualify if:

• age: 18 - 45 years
• sex: male
• body weight: 18 kg/m² to 26 kg/m²
• good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state
• body weight: 18 kg/m² to 26 kg/m²
• written informed consent

You may not qualify if:

• existing cardiac or hematological diseases and/or pathological findings which might interfere with safety, pharmacodynamic effect and/or pharmacokinetics of metformin
• existing hepatic and renal diseases and/or pathological findings which might interfere with safety, pharmacodynamic effect and/or pharmacokinetics of metformin
• existing gastrointestinal diseases and/or pathological findings which might interfere with safety, pharmacodynamic effect and/or pharmacokinetics of metformin
• acute or chronic diseases which could affect drug absorption or metabolism
• history of any serious psychological disorder
• drug or alcohol dependence
• smokers of 10 or more cigarettes per day
• positive screening results for HIV, HBV and HCV
• volunteers who are on a diet which could affect the pharmacokinetics of the drug
• heavy tea or coffee drinkers (more than 1L per day)
• lactation and pregnancy test positive or not performed
• volunteers suspected or known not to follow instructions
• blood donation or other blood loss of more than 400 ml within the last 12 weeks prior to the start of the study
• participation in a clinical trial during the last 3 months prior to the start of the study
• less than 14 days after last acute disease

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of pharmacy, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Location

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• AiDong Wen, Pro

  Department of pharmacy, Xijing Hospital, Fourth Military Medical University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 22, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

CN (1)