Pharmacokinetics of Voriconazole in Obese Subjects

NCT01030653 Phase 4 COMPLETED Results posted

Obese subjects may require a higher fixed oral maintenance dosing regimen of voriconazole compared to normal weight subjects to achieve comparable plasma exposures. The current study is designed to address this issue.

Details

Lead sponsor	Manjunath Prakash Pai
Phase	Phase 4
Status	COMPLETED
Enrolment	10
Start date	2009-11
Completion	2010-05

Conditions

• Healthy

Interventions

• Voriconazole low dose
• Voriconazole high dose

Primary outcomes

• Steady-State Cmax and Cmin of Two Voriconazole Dosing Regimens — Day 5
  Cmax is the maximum concentration, and Cmin is the minimum concentration. These measurements are based on analysis of plasma. The units shown are milligrams of voriconazole per liter of plasma. The two dosing regimens are: 1. a loading dose (400 mg x 2 doses, day 1) and maintenance doses (200 mg every 12 hours x 7 doses) in obese subjects. 2. a loading dose (400 mg x 2 doses, day 1) and maintenance doses (300 mg every 12 hours x 7 doses) in obese subjects.
• Geometric Mean Ratio of the AUC Between the High and Low Dose Voriconazole — 14 days
  AUC is the area under the concentration-time curve. The Geometric Mean Ratio and 90% confidence interval around this value permit an assessment of the bioequivalence of two dosing regimens in the same group. The geometric mean is computed based on the ratio of the AUC value from the high dose compared to the AUC value from the low dose for each individual. This ratio provides a more robust interpretation of the differences between the two dosing arms because each individual serves as their own control.

Countries

United States