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Bioequivalence Study in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00844324
First received: February 12, 2009
Last updated: December 6, 2010
Last verified: December 2010
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Single Dose, 2-Period, Cross-over, Bioequivalence Study in Healthy Subjects to Evaluate the Proposed Commercial Oral Suspension of Candesartan Cilexetil

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 36
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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

  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

Locations
United Kingdom
Research Site
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: James Hainer, Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00844324     History of Changes
Other Study ID Numbers: D2451C00007
Study First Received: February 12, 2009
Last Updated: December 6, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Candesartan
Bioequivalence

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Candesartan cilexetil
Candesartan
Angiotensin II Type 1 Receptor Blockers
 Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013