MedTrace Logo

Bioequivalence Study in Healthy Subjects

NCT00844324 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-12-07

No results posted yet for this study

Summary

This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial oral suspension of candesartan cilexetil (1 mg/mL) and a single 32 mg dose of the candesartan cilexetil oral suspension (1.6 mg/mL) used in the paediatric program.

Conditions

Interventions

DRUG

Candesartan cilexetil

Formulation:Oral suspensionStrength:1 mg/mLDose: 32 mg, single dose

DRUG

Candesartan cilexetil

Formulation:Oral suspensionStrength:1.6 mg/mLDose: 32 mg, single dose

Sponsors & Collaborators

Principal Investigators

  • James Hainer, MD · AstraZeneca

  • Klaus Francke, Dr · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00844324 on ClinicalTrials.gov