Bioequivalence Study in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00844324
Recruitment Status : Completed
First Posted : February 16, 2009
Last Update Posted : December 7, 2010
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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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier (NCT number): NCT00844324

United Kingdom
Research Site
Harrow, United Kingdom
Sponsors and Collaborators
Study Director: James Hainer, MD AstraZeneca
Principal Investigator: Klaus Francke, Dr Parexel

Responsible Party: James Hainer, Medical Science Director, AstraZeneca 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:

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