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

Brief summary:
This study will evaluate the relative bioavailability of the new SSP-004184SS capsule formulation compared to the original SSP-004184AQ drug plus excipients formulation.

Detailed description:

Arms:
arm 1: 40 mg/kg (oral capsule form) given once on Day 1 arm 2: 21.8 mg/kg (oral capsule form) given once on Day 1 arm 3: 40 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1 arm 4: 21.8 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1

Interventions: intervention 1: SSP-004184AQ intervention 2: SSP-004184SS
Intervention descriptions: intervention 1: Magnesium salt intervention 2: Disodium salt

Protocol document: