Bioequivalence Study in Healthy Subjects
Study identifier:D2451C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Single Dose, 2-Period, Cross-over, Bioequivalence Study in Healthy Subjects to Evaluate the Proposed Commercial Oral Suspension of Candesartan Cilexetil
Medical condition
hypertension
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Candesartan cilexetil
Sex
All
Actual Enrollment
36
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Mar 2009
Primary Completion Date: 01 Jun 2009
Study Completion Date: 01 Jun 2009
Study design
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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: A Candesartan cilexetil 1mg/mL | Drug: Candesartan cilexetil Formulation:Oral suspensionStrength:1 mg/mLDose: 32 mg, single dose |
| Experimental: B Candesartan cilexetil 1.6mg/mL | Drug: Candesartan cilexetil Formulation:Oral suspensionStrength:1.6 mg/mLDose: 32 mg, single dose |
Contacts
Investigators
Principal Investigator
James Hainer
AstraZeneca
