The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 100mg Compared With Compressed Tablet 100 mg
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomised, parallel-group study to demonstrate the bioequivalence of
      lamotrigine 100mg in two different formulations, dispersible/chewable tablet and compressed
      tablet, in healthy subjects under fasting conditions. Subjects will be randomized in equal
      numbers to be dosed with either lamotrigine dispersible/chewable (Test) 100mg tablet or
      lamotrigine compressed (Reference) 100mg tablet. Pharmacokinetic blood sampling will be
      collected over 216 hours post dose. Safety (tolerability) will be observed up to 216 hours
      post dose. Safety assessments will include regular monitoring of vital signs, ECG's, adverse
      events (AEs) and safety laboratory tests. A follow-up visit is scheduled within 10-17 days
      post-dose.
    

Detailed description: 
      This is a single dose, open-label, randomized, parallel-group study to demonstrate the
      bioequivalence of lamotrigine dispersible/chewable tablet and lamotrigine compressed tablet
      at 100mg in healthy Chinese male subjects in fasting conditions. Approximate 138 Chinese
      healthy male subjects will be enrolled in accordance with the inclusion and exclusion
      criteria. Subjects will be 18 to 45 years, healthy and body mass index between 19-24 kg/m2
      and sign the informed consent.

      Having given written informed consent, subjects will be required to undergo a pre-study
      medical screen within 14 days of the dosing day. Subjects will be admitted on Day 0 (the day
      before dosing) and will stay in the unit until after the 24-hour post-dose assessments on Day
      2. The time that a subject is discharged from the unit may be agreed with unit staff but
      subjects must return for all designated pharmacokinetic (PK) samples and on scheduled time
      for observation.

      The subjects will be randomized in equal numbers to be dosed under fasting conditions with
      either lamotrigine dispersible/chewable tablet or lamotrigine compressed tablet. The
      pharmacokinetic assessment will last 10 days. The blood samples will be collected immediately
      before dosing (pre-dose) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120,
      144, 168 and 216 hours post dose for determination of lamotrigine concentration in blood.
      Safety and tolerability evaluation will be observed up to 216 hours post-dose, including
      adverse events, vital signs, physical examination, electrocardiogram. All subjects will be
      required to undergo a follow-up assessment within 10-17 days after receiving the study
      medication.
    

Intervention name(s): Lamotrigine Dispersible/Chewable tablet; Lamotrigine Compressed tablet
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of lamotrigine dispersible/chewable 100mg tablet at Day1; Single dose of lamotrigine compressed 100mg tablet at Day1
Other intervention name(s): Lamictal; Lamictal
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment