Drug Interaction Clinical Trial
Official title:
An Open Label, Randomized, Single-dose, Fixed-Sequence Crossover Drug Interaction Study of Loperamide HCL With Grapefruit Juice
A 10-day study to determine if grapefruit juice has any effect on how loperamide (Imodium) affects the body and how the body affects loperamide.
An open-label, randomized, single-dose, fixed-sequence crossover drug interaction study of loperamide HCl with grapefruit juice. About 33 healthy subjects, about equal numbers of men and women, 18 through 59 years of age, will be enrolled into this 10 day trial. Subjects will be divided into three cohorts of about 11 subjects each. Each cohort will receive red, white or pink grapefruit juice. Subjects will take 4 mg of loperamide on Day 1. They will ingest 8 ounces of grapefruit juice and then 4 mg of loperamide on Day 3. They will ingest 8 ounces of grapefruit juice in the morning and in the evening on Days 5, 6 and 7. On Day 8, subjects will ingest 8 ounces of juice and then 4 mg of loperamide. Blood samples will be collected at at predose (0) and 0.5, 1, 1.5, 32, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36 and 46 hours after dosing on Day 1, Day 3 and Day 8. Pupillometry assessments will be performed at pre-dose (0) and 2, 4, 6, 8, and 12 hours after dosing on Day 1, Day 3 and Day 8. Subjects will collect their urine from about 8 PM to about 6 AM prior to dosing on Day 1, Day 3 and Day 8. ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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