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Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects

NCT02080780 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-04-14

Study results available
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Summary

The purpose of this study is to evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.

Conditions

  • CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]

Interventions

DRUG

Clarithromycin XL

Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg

DRUG

2% Diltiazem

2% Diltiazem Hydrochloride Cream applied on Day 1 \& Day 8 to the perianal area (\~2.5 cm \[1 inch\]; \~8.5 mg)

Sponsors & Collaborators

  • TKL Research, Inc.

    collaborator INDUSTRY

  • Ventrus Biosciences, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

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 NCT02080780 on ClinicalTrials.gov