Bioequivalence Study in Healthy Subjects - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00844324

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Candesartan cilexetil	Phase I

MedlinePlus related topics: High Blood Pressure

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, 2-Period, Cross-Over, Bioequivalence Study in Healthy Subjects to Evaluate the Proposed Commercial Oral Suspension of Candesartan Cilexetil

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

PK (Candesartan cilexetil) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety variables (adverse events, ECG, vital signs, safety laboratory) [ Time Frame: During the whole treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	52
Study Start Date:	March 2009
Estimated Study Completion Date:	June 2009

Arms	Assigned Interventions
A: Experimental Candesartan cilexetil 1mg/mL	Drug: Candesartan cilexetil Formulation:Oral suspensionStrength:1 mg/mLDose: 32 mg, single dose
B: Experimental Candesartan cilexetil 1.6mg/mL	Drug: Candesartan cilexetil Formulation:Oral suspensionStrength:1.6 mg/mLDose: 32 mg, single dose

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844324

Contacts

Contact: AstraZeneca Clinical Study Information	800-236-9933	information.center@astrazeneca.com
Contact: Philipp Peele	49 30 30685-9313	philipp.peele@parexel.com

Locations

United Kingdom
Research Site	Recruiting
Harrow, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	James Hainer, MD	AstraZeneca
Principal Investigator:	Klaus Francke, Dr	Parexel

More Information

No publications provided

Responsible Party:	AstraZeneca ( James Hainer, Medical Science Director )
Study ID Numbers:	D2451C00007
Study First Received:	February 12, 2009
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00844324 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Candesartan
Bioequivalence

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Candesartan
Vascular Diseases
Cardiovascular Agents

Healthy
Angiotensin II
Antihypertensive Agents
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Candesartan
Vascular Diseases

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009