CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 45 enrolled
Drug / intervention
Digoxin +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03307252
NCT03307252Phase 1Completed

The Effect of Potent Inhibitors of Drug Transporters (Verapamil, Rifampin, Cimetidine, Probenecid) on Pharmacokinetics of a Transporter Probe Drug Cocktail Consisting of Digoxin, Furosemide, Metformin and Rosuvastatin (an Open-label, Randomised, Crossover Trial in Three Parts)

Boehringer Ingelheim·interventional·Posted Oct 11, 2017·Updated Nov 7, 2023

In Brief

A Phase 1 clinical trial evaluating Digoxin, Furosemide, and 6 other interventions for Healthy. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 11, 2017
Enrollment StartOct 25, 2017
Primary CompletionMay 2, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.7 years ago

Interventions

Digoxindrug

Tablet

Furosemidedrug

Oral solution

Metformindrug

Oral solution

Rosuvastatindrug

Film-coated tablet

Verapamildrug

Film-coated tablet

Rifampindrug

Film-coated tablet

Cimetidinedrug

Tablet

Probeneciddrug

Tablet