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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases
Candesartan
Candesartan cilexetil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014