Lofexidine Food Effect Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      This is a single-dose, open-label, randomized, two-period, two-way crossover, food-effect
      study in which 12 healthy adult subjects will receive two separate single-dose
      administrations of lofexidine 400 μg (2 x 200 μg tablet). In one study period, subjects will
      be administered the study treatment following an overnight fast of at least 10 hours. In the
      other study period subjects will fast overnight for at least 10 hours, then begin consuming
      an FDA standard high-calorie, high-fat breakfast meal 30 minutes prior to administration of
      the study drug.

      Subjects will be assigned numbers in an ascending order, based on successful completion of
      the screening process.

      Subjects will receive each of the treatments listed below in randomized fashion during the
      two treatment periods:

      Treatment A: Test Formulation Lofexidine 400 μg Dose = 2 x 200 μg tablet administered under
      fasted conditions US WorldMeds, LLC

      Treatment B: Test Formulation Lofexidine 400 μg Dose = 2 x 200 μg tablet administered under
      fed conditions US WorldMeds, LLC

      Each drug administration will be separated by a washout period of at least seven days. Each
      dose will be orally administered along with 240 mL (8 fl. oz.) of room temperature tap water.
      After dosing, no food will be allowed until 4 hours post-dose. Except for the 240 mL of room
      temperature tap water provided with the dose, no water may be consumed for 1 hour prior
      through 1 hour post dose. Meals will be the same and scheduled at approximately the same
      times relative to dose for each study period.

      In order to prevent adverse events (AEs) of hypotension, all subjects will have intravenous
      (IV) access established at each check-in and will be administered normal saline (NS) at a
      continuous rate of 150 cc/hour until 1 hour prior to each dose administration. The IV
      catheter will remain in place for at least 12 hours postdose so that additional fluid can be
      administered if needed. If symptoms or clinically significant hypotension persist, IV fluid
      administration may continue for more than 12 hours, until it is no longer needed as
      determined by the Investigator.

      Subjects who withdraw from the study may be replaced. During each study period, 6 mL blood
      samples will be obtained prior to each dosing and following each dose at selected times
      through 48 hours post-dose. A total of 28 pharmacokinetic blood samples will be collected
      from each subject, 14 samples in each study period. Plasma pharmacokinetic samples will be
      analyzed for lofexidine using a validated analytical method. Appropriate pharmacokinetic
      parameters will be calculated for each formulation using non-compartmental methods. In
      addition, blood will be drawn and urine will be collected for clinical laboratory testing at
      screening and at the end of the study.
    

Intervention name(s): Lofexidine HCl
Intervention type(s): Drug
Intervention description(s): 400 mcg (2 x 200 mcg tablets) administered orally as a single dose
Intervention MeSH terms: Lofexidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lofexidine; food effect; pharmacokinetics; healthy volunteer