Bioequivalence Study in Healthy Subjects
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Candesartan cilexetil (Drug); Candesartan cilexetil (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): James Hainer, MD, Study Director, Affiliation: AstraZeneca Klaus Francke, Dr, Principal Investigator, Affiliation: Parexel
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: PK (Candesartan cilexetil)
Secondary outcome: Safety variables (adverse events, ECG, vital signs, safety laboratory)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Research Site, Harrow, United Kingdom
Additional Information
Starting date: March 2009
Last updated: December 6, 2010
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