A Single-Dose, Open-Label, Randomized, Two-Way Crossover Food Effect Study of Lofexidine 400 μg (2 x 200 μg) Tablets

NCT01437306 Phase 1 COMPLETED

The objective of this single-dose, open-label, randomized, two-period, two-way crossover, food-effect study is to evaluate the effect of food on the rate of absorption and oral bioavailability of a test formulation of lofexidine 400 μg (2 x 200 μg tablet) manufactured by US WorldMeds, LLC.

Details

Lead sponsor	USWM, LLC (dba US WorldMeds)
Phase	Phase 1
Status	COMPLETED
Enrolment	13
Start date	2011-10
Completion	2011-10

Conditions

• Healthy

Interventions

• Lofexidine HCl

Primary outcomes

• Comparative Profile Pharmacokinetics TimeFrame 0.5, 1, 2, 3, 4, 5, 7, 10, 16, 24, 30, 36 and 48 hours post dose for Cmax, Tmax, Area Under the Curve, Elimination Rate Constant and Elimination Half Life — 48 Hours Following Each Dose
  Samples will be analyzed for lofexidine concentration and calculations will be performed for the following: Cmax and Tmax will be taken directly from the data. The elimination rate constant, will be calculated as the negative of the slope of the terminal log-linear segment of the plasma concentration time curve. Elimination half-life (T½) as follows: T½ = ln(2) / λZ Area under the curve will be calculated using the linear trapezoidal method and extrapolated to infinity using: AUCinf = AUClast + Clast/ λZ where Clast is the final concentration LOQ.

Countries

United States