Study identifier:D1250C00056
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A phase I, single-centre, open, randomized, two-way crossover study to evaluate the pharmacokinetics of the extended-release test formulation of AZD0837 compared to the extended-release AZD0837 reference formulation after repeated dosing in healthy volunteers
Healthy
Phase 1
Yes
AZD0837
All
36
Interventional
18 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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No locations available
Arms | Assigned Interventions |
---|---|
Experimental: HAB AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast | Drug: AZD0837 Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days |
Experimental: HBA AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast | Drug: AZD0837 Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days |
Experimental: LAB AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast | Drug: AZD0837 Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days |
Experimental: LBA AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast | Drug: AZD0837 Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days |