Study identifier:D3190C00016
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomised, Open, Single-centre study to Evaluate the Pharmacokinetics of Different Extended-release Formulations of AZD1305 When Given as Single and Repeated Oral Doses to Healthy Male Volunteers
Healthy
Phase 1
Yes
AZD1305
Male
24
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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The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.
Location
Location
HARROW, United Kingdom
Arms | Assigned Interventions |
---|---|
Experimental: Part A: 3 way crossover AZD1305: ER test formulation 1 (w/wo food) and reference formulation | Drug: AZD1305 Single Oral Dose, ER formulation 1 |
Experimental: Part B1: single arm AZD1305: ER test formulation 1 | Drug: AZD1305 ER formulation 1, bid for 5 days |
Experimental: Part B2: 3 way crossover AZD1305: ER test formulation 2 (w/wo food) and reference formulation | Drug: AZD1305 Single Oral Dose, ER formulation 2 |
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