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Drug-drug Interaction (DDI) Study of Spironolactone (Perpetrator) and Digoxin (Substrate Drug)

NCT03909529 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-05-01

Study results available
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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.

Conditions

  • Drug Drug Interaction

Interventions

DRUG

Digoxin 250 MCG Oral Tablet

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

DRUG

Spironolactone 25 mg/ 5 mL S/F Suspension

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

Sponsors & Collaborators

  • CMP Development, LLC

    lead INDUSTRY

Principal Investigators

  • Roopali K Somani, MD · Employee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-10
Primary Completion
2019-04-19
Completion
2019-04-30
FDA Drug
Yes

Countries

  • India

Study Locations

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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 NCT03909529 on ClinicalTrials.gov