SCH 465981: Assessment of Bi-Directional Interaction Between Components of Vytorin® (Ezetimibe and Simvastatin) and Niaspan® (Niacin Extended-Release Tablets) in Healthy Subjects

NCT00652431 Phase 1 COMPLETED

This is a single-center, randomized, open-label, 3-period, 3-treatment multiple-dose crossover study designed to assess the interaction between VYTORIN® (Ezetimibe and Simvastatin) and NIASPAN® (Niacin Extended-Release Tablets) in healthy subjects. Treatment spans 7 days

Details

Lead sponsor	Organon and Co
Phase	Phase 1
Status	COMPLETED
Enrolment	18
Start date	2007-05
Completion	2007-07

Conditions

• Hypercholesterolemia
• Hyperlipidemia

Interventions

• Vytorin + Niaspan
• Vytorin
• Niaspan

Primary outcomes

• Evaluate the potential for a PK interaction between NIASPAN and components of VYTORIN, using Tmax, Cmax, and AUC. — Day 7