A 5-treatment, Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release (CR) Pregabalin Tablet Formulations and the Immediate Release (IR) Formulation Administered Fasted
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, single dose, randomized, 5-period, 5-treatment, 4-sequence
      cross-over with a fixed 5th treatment arm. Subjects will receive in a randomized sequence a
      330 mg CR tablet with fast in vitro dissolution rate, a 330 mg CR tablet with slow in vitro
      dissolution rate, a heavier 330 mg CR tablet with fast in vitro dissolution rate or a 330 mg
      market image reference CR tablet. Subjects will receive a 300mg IR formulation in the 5th
      period to to estimate and compare the % of dose absorbed versus time profile for the three CR
      prototype tablets and the CR reference tablet.
    


Intervention name(s): Sequence 1 - Treatment A: Controlled Release Pregabalin; Sequence 1 - Treatment B: Controlled Release Pregabalin; Sequence 1 - Treatment C:Controlled Release Pregabalin; Sequence 1 - Treatment D: Controlled Release Pregabalin; Sequence 1 - Treatment E: Immediate Release Pregabalin; Sequence 2 - Treatment B: Controlled Release Pregabalin; Sequence 2 - Treatment D: Controlled Release Pregabalin; Sequence 2 - Treatment A: Controlled Release Pregabalin; Sequence 2 - Treatment C: Controlled Release Pregabalin; Sequence 2 - Treatment E: Immediate Release Pregabalin; Sequence 3 - Treatment C: Controlled Release Pregabalin; Sequence 3 - Treatment A: Controlled Release Pregabalin; Sequence 3 - Treatment D: Controlled Release Pregabalin; Sequence 3 - Treatment B: Controlled Release Pregabalin; Sequence 3 - Treatment E: Immediate Release Pregabalin; Sequence 4 - Treatment D: Controlled Release Pregabalin; Sequence 4 - Treatment C: Controlled Release Pregabalin; Sequence 4 - Treatment B: Controlled Release Pregabalin; Sequence 4 - Treatment A: Controlled Release Pregabalin; Sequence 4 - Treatment E: Immediate Release Pregabalin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.; 300 mg IR capsule administered in the evening in the fasted state.; 330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 300 mg IR capsule administered in the evening in the fasted state.; 330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 300 mg IR capsule administered in the evening in the fasted state.; 330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.; 300 mg IR capsule administered in the evening in the fasted state.
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetic; relative oral bioavailability; pregabalin