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Completed

NCT Number: NCT00844324

Bioequivalence Study in Healthy Subjects

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Harrow, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Candesartan cilexetil

Drug

Formulation:Oral suspensionStrength:1 mg/mLDose: 32 mg, single dose

Primary outcomes

  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 outcomes

  1. Safety variables (adverse events, ECG, vital signs, safety laboratory)

    Time frame: During the whole treatment period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Single Dose, 2-Period, Cross-over, Bioequivalence Study in Healthy Subjects to Evaluate the Proposed Commercial Oral Suspension of Candesartan Cilexetil

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 16, 2009
Registry last updated
Dec 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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