CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Digoxin 250 MCG Oral Tablet +1 moredrug
Likely dose
Digoxin 250 MCG Oral Tabletfrom 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/NCT03909529
NCT03909529Phase 1Completed
CompareCT.gov

Two Way Crossover Oral Drug-drug Interaction Study of Spironolactone (Perpetrator) and Digoxin (Substrate Drug) in Healthy Adult Human Subjects Under Fasting Condition

CMP Development, LLC·interventional·Posted Apr 10, 2019·Updated May 1, 2023

In Brief

A Phase 1 clinical trial evaluating Digoxin 250 MCG Oral Tablet and Spironolactone 25 mg/ 5 mL S/F Suspension for Drug Drug Interaction. Completed, enrolled 28 participants across 1 site.

Detailed Summary

An open label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, crossover oral drug-drug interaction study of spironolactone (perpetrator) and Digoxin (substrate drug) in healthy adult human subjects under fasting condition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Drug Interaction
CountriesIndia
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedApr 10, 2019
Enrollment StartMar 10, 2019
Primary CompletionApr 19, 2019
Study CompletionApr 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.2 years ago

Interventions

Digoxin 250 MCG Oral Tabletdrug

The intervention is for study of drug drug interaction of digoxin when administered with spironolactone oral suspension

Spironolactone 25 mg/ 5 mL S/F Suspensiondrug

The intervention is for study of drug drug interaction of digoxin when administered with spironolactone oral suspension