Status:
COMPLETED
Bioequivalence Study in Healthy Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Hypertension
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00844324
Start Date
March 1 2009
End Date
June 1 2009
Last Update
December 7 2010
Active Locations (1)
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1
Research Site
Harrow, United Kingdom