Bioequivalence Study in Healthy Subjects

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Candesartan; Candesartan cilexetil

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