Conditions: Bioequivalence of the Test Formulation
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
Bioequivalence evaluation of Nurofen for Children® with reference formulation of Algifor® Junior by determining and comparing the rate and extent of absorption in both fed and fasted states

Detailed description:

Arms:
arm 1: Nurofen for Children® 400 mg/10 ml by mouth under fed condition

Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA. arm 2: Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.

Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA. arm 3: Algifor® Junior 400 mg/20 ml by mouth under fed condition.

Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA. arm 4: Algifor® Junior 400 mg/20 ml by mouth under fasted condition.

Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.

Interventions: intervention 1: Nurofen for Children® intervention 2: Algifor® Junior
Intervention descriptions: intervention 1: Nurofen for Children® 400 mg/10 ml intervention 2: Algifor® Junior 400 mg/20 ml

Protocol document: