Conditions: Reflux
Keywords: Pharmacodynamic effect Reflux inhibition
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: yes

Brief summary:
The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.

Detailed description:
A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers.

Arms:
arm 1: period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg. arm 2: period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg. arm 3: period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo. arm 4: period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg

Interventions: intervention 1: AZD2516, 5 mg intervention 2: AZD2516, 16 mg intervention 3: AZD2516, 40 mg intervention 4: Placebo
Intervention descriptions: intervention 1: Capsule, oral intervention 2: Capsule, oral intervention 3: Capsule, oral intervention 4: Capsule, oral

Protocol document: