Conditions: ADHD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 28
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess bioequivalence of 2 capsule strengths.

Detailed description:
This will be a randomised, open-label, two-period, single dose, crossover bioequivalence study in healthy subjects under fasting conditions to assess bioequivalence of 1 x 60 mg capsule methylphenidate compared to 2 x 30 mg capsules methylphenidate. Pharmacokinetics and safety will be assessed.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: SPD544 intervention 2: Methylphenidate hydrochloride
Intervention descriptions: intervention 1: two 30mg capsules, single oral dose intervention 2: one 60mg capsule, single oral dose

Protocol document: