The effect of dipyridamole on the pharmacokinetics of metformin.

Phase 1

• Conditions: The antihyperglycemic drug metformin and the thrombocyte aggregation inhibitor dipyridamole are often used concomitantly in patients with diabetes who have suffered a transient ischemic attack or stroke. Gastrointestinal absorption of metformin is mediated by the equilibrative nucleoside transporter 4 (hENT4). Dipyridamole has been reported to inhibit hENT4 transport in vitro. Dipyridamole may therefore negatively influence the uptake of metformin from the gastrointestinal tract.; MedDRA version: 14.1Level: PTClassification code 10068071Term: Inhibitory drug interactionSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Body processes [G] - Chemical Phenomena [G02]; MedDRA version: 14.1Level: PTClassification code 10013710Term: Drug interactionSystem Organ Class: 10018065 - General disorders and administration site conditions

• Registration Number: EUCTR2012-000363-24-NL
• Lead Sponsor: Radboud University Medical Centre Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-22
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

- Age 18-50 years
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Smoking
- Hypertension (systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg)
- Diabetes Mellitus (fasting glucose >7 mmol/L or random glucose >11 mmol/L)
- History of any cardiovascular disease
- Renal dysfunction (MDRD <60 ml/min)
- ECG abnormalities, other than first grade AV-block or right bundle branch block

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study whether dipyridamole reduces gastrointestinal absorption of metformin.;Secondary Objective: Not applicable.;Primary end point(s): The area under the curve of the metformin plasma concentration of metformin at t=0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, and 10 hours after the intake of the last tablet of metformin and the Cmax.;Timepoint(s) of evaluation of this end point: t=0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, and 10 hours after the intake of the last tablet of metformin

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.