The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 5mg×5 Compared With Lamotrigine Compressed Tablet 25mg in Chinese Healthy Male Subjects
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose, open-label, randomized, two-period crossover study to demonstrate the
      bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine compressed
      tablets (25mg) in healthy Chinese male subjects in fasting conditions. The safety,
      tolerability and pharmacokinetic profile of lamotrigine dispersible/chewable tablets will
      also be assessed.
    

Detailed description: 
      This is a single dose, open-label, randomized, two-period crossover study to demonstrate the
      bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine compressed
      tablets (25mg) in healthy Chinese male subjects in fasting conditions. 24 healthy Chinese
      male subjects will be enrolled to provide data from at least 22 evaluable subjects . In
      Period 1, subjects will be randomized in equal numbers to be dosed with either lamotrigine
      dispersible/chewable 5mg×5 tablets or lamotrigine compressed tablet 25mg×1. Following a
      washout of at least 14 days, subjects will be crossed over in Period 2 to receive the
      treatment that they did not receive in Period 1.

      Pharmacokinetic blood samples will be collected over 168 hours post dose. Venous blood (2 ml
      each) is taken immediately before dosing (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,
      24, 36, 48, 72, 96, 120, 144 and 168 hours post dose to determine the lamotrigine
      concentration in serum. Drug concentration in serum at different time points will be
      determined for each subject with a validated bioanalytical method using LC/MS/MS method. The
      main pharmacokinetic parameters such as Cmax, tmax, AUC(0-inf), AUC(0-t), t1/2, λz, CL/F and
      Vd/F are calculated for subjects using non-compartment analysis method.

      Physical examination, electrocardiogram and clinical laboratory tests are conducted at
      screening and 168 hours after administration of each dose; vital signs are measured at
      scheduled time; adverse events are recorded throughout the study. Clinically relevant safety
      measurement values are tabulated to evaluate the safety and tolerability of lamotrigine
      dispersible/chewable tablet. Safety evaluation lasts up to 168 hours after the second oral
      administration.
    

Intervention name(s): Lamotrigine Dispersible/Chewable tablets 5mg*5; Lamotrigine Compressed tablet 25mg
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg*1 tablet at Day15; Single dose of lamotrigine compressed 25mg*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day15
Other intervention name(s): Lamictal; Lamictal
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment