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This Study Tests the Effect of Certain Medicines on the Transport of Other Medicines in the Body of Healthy Men

NCT03307252 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-11-07

Study results available
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Summary

The primary objective of this trial is to investigate the relative bioavailabilities of digoxin, furosemide, metformin and rosuvastatin given as a cocktail alone and as a cocktail together with the following drug transporter inhibitors:

Part 1: verapamil (P-gp) and rifampin (OATP1B1/1B3) Part 2: cimetidine (OCT2/MATE) Part 3: probenecid (OAT1/3) The secondary objective is to investigate other potential changes in pharmacokinetics (e.g. in clearance, volume of distribution, etc.) of digoxin, furosemide, metformin and rosuvastatin given as a cocktail alone and as a cocktail together with the inhibitors describe above.

Conditions

  • Healthy

Interventions

DRUG

Digoxin

Tablet

DRUG

Furosemide

Oral solution

DRUG

Metformin

Oral solution

DRUG

Rosuvastatin

Film-coated tablet

DRUG

Verapamil

Film-coated tablet

DRUG

Rifampin

Film-coated tablet

DRUG

Cimetidine

Tablet

DRUG

Probenecid

Tablet

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2018-05-02
Completion
2018-05-02

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03307252 on ClinicalTrials.gov