Bioequivalence Study in Healthy Subjects

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

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.

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