At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Clarithromycin XL +1 moredrug
Likely dose
Clarithromycin XL 500 mgfrom 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.
Phase 1, Open-label, Drug-drug Interaction Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Clarithromycin XL and 2% Diltiazem for CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsTKL Research, Inc.
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
Primary CompletionOct 2013
First PostedMar 2014
TodayJul 2026
First PostedMar 6, 2014
Enrollment StartSep 1, 2013
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 12.3 years ago
Interventions
Clarithromycin XLdrug
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
2% Diltiazemdrug
2% Diltiazem Hydrochloride Cream applied on Day 1 \& Day 8 to the perianal area (\~2.5 cm \[1 inch\]; \~8.5 mg)