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Clarithromycin XL · 1 trial · 1 indication
To evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.
| Arm | Type | Description |
|---|---|---|
| 2% Diltiazem & Clarithromycin XL | EXPERIMENTAL | 3 parts: 1. \- Single Dose, Diltiazem (Day 1) 2. \- Multiple Dose, Clarithromycin XL (Days 4-9) 3. \- Single Dose, Diltiazem (Day 8) |
| Name | Type | Description |
|---|---|---|
| Clarithromycin XL | DRUG | 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% Diltiazem | DRUG | 2% Diltiazem Hydrochloride Cream applied on Day 1 \& Day 8 to the perianal area (\~2.5 cm \[1 inch\]; \~8.5 mg) |
Inclusion Criteria: 1. Were healthy subjects (as confirmed by medical history, laboratory work, and physical exam); 2. Were between 18 and 60 years of age, inclusive; 3. If of childbearing potential, were using an acceptable form of birth control (ie, nonhormonal intra-uterine device, diaphragm, co...