Bioequivalence Study in Healthy Subjects

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Hypertension

Treatments

Drug: Candesartan cilexetil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00844324

D2451C00007

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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