Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets.
Study identifier:D4320C00029
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Randomised, Single-blind, Single-centre, Incomplete-block Crossover, Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
ZD4054
Sex
Male
Actual Enrollment
20
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Jun 2008
Primary Completion Date: -
Study Completion Date: 01 Aug 2008
Study design
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 There are 5 variations of the ZD4054 (Zibotentan) 10mg tablet - A, B, C, D, and E. A minimum washout period of 1 week will occur between each treatment period. | Drug: ZD4054 Treatment period 1: 10mg oral solution Other Name: Zibotentan Drug: ZD4054 Treatment period 2: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice. Other Name: Zibotentan Drug: ZD4054 Treatment period 3: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice. Other Name: Zibotentan Drug: ZD4054 Treatment period 4: 3 of the 5 tablet variations (A-E) to be taken in a random sequence, but not the same tablet twice. Other Name: Zibotentan |
Contacts
Investigators
Principal Investigator
Sylvan Hurewitz
AZ Clinical Pharmacology Unit, Philadelphia, USA
