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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Harrow, United Kingdom

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

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1264&filename=CSR-D2451C00007.pdf
Download
CSR-D2451C00007.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Contact Backup

Philipp Peele

49 30 30685-9313

philipp.peele@parexel.com

Investigators

Principal Investigator

James Hainer

AstraZeneca