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Bioequivalence Study in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00844324
Recruitment Status : Completed
First Posted : February 16, 2009
Last Update Posted : December 7, 2010
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Candesartan cilexetil Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety variables (adverse events, ECG, vital signs, safety laboratory) [ Time Frame: During the whole treatment period ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: James Hainer, Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00844324     History of Changes
Other Study ID Numbers: D2451C00007
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Candesartan
Bioequivalence

Additional relevant MeSH terms:
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action