Conditions: CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: yes

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

Detailed description:
This study was designed to investigate the potential effect of clarithromycin XL at steady state (administered orally, once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg) on the PK of a single topical dose of diltiazem hydrochloride 2% cream applied to the perianal area (\~2.5 cm \[1 inch\]; \~8.5 mg). This was a Phase 1 study with a single treatment arm. Efficacy was not assessed; therefore the study was of open-label design.

Arms:
arm 1: 3 parts:

1. \- Single Dose, Diltiazem (Day 1)
2. \- Multiple Dose, Clarithromycin XL (Days 4-9)
3. \- Single Dose, Diltiazem (Day 8)

Interventions: intervention 1: Clarithromycin XL intervention 2: 2% Diltiazem
Intervention descriptions: intervention 1: 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 intervention 2: 2% Diltiazem Hydrochloride Cream applied on Day 1 \& Day 8 to the perianal area (\~2.5 cm \[1 inch\]; \~8.5 mg)

Protocol document: