NCT00844324

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 7, 2010

Status Verified

December 1, 2010

Enrollment Period

3 months

First QC Date

February 12, 2009

Last Update Submit

December 6, 2010

Conditions

Hypertension

Keywords

CandesartanBioequivalence

Outcome Measures

Primary Outcomes (1)

  • PK (Candesartan cilexetil)

    Collected at pre-dose and at selected time points; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30 and 36 hours post-dose

Secondary Outcomes (1)

  • Safety variables (adverse events, ECG, vital signs, safety laboratory)

    During the whole treatment period

Study Arms (2)

A

EXPERIMENTAL

Candesartan cilexetil 1mg/mL

Drug: Candesartan cilexetil

B

EXPERIMENTAL

Candesartan cilexetil 1.6mg/mL

Drug: Candesartan cilexetil

Interventions

Candesartan cilexetilDRUG

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

A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • Body mass index (BMI) 19-27 kg/m2 calculated from height and weight at the Screening visit
  • Clinically normal physical findings including ECG and safety laboratory values at the Screening visit and on Day -1 of each treatment period, including negative results for drugs-of-abuse, alcohol, Hepatitis B, Hepatitis C and HIV.

You may not qualify if:

  • History of significant mental, cardiac, renal, hepatic or significant gastrointestinal disease (that may affect the rate and extent of absorption of the IP), as judged by the Investigator
  • Any condition which could modify the absorption of the IPs
  • Previous randomisation of treatment in the present study
  • History or symptoms and signs of ongoing severe allergic disease/hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Harrow, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Interventions

candesartan cilexetil

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • James Hainer, MD

    AstraZeneca

    STUDY DIRECTOR

  • Klaus Francke, Dr

    Parexel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 16, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 7, 2010

Record last verified: 2010-12

Locations

GB(1)