Hypertension
Conditions
Keywords
Candesartan, Bioequivalence
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 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.
Interventions
DRUGCandesartan cilexetil
Formulation:Oral suspensionStrength:1 mg/mLDose: 32 mg, single dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK (Candesartan cilexetil) | Collected at pre-dose and at selected time points; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30 and 36 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables (adverse events, ECG, vital signs, safety laboratory) | During the whole treatment period |
Countries
United Kingdom
Outcome results
None listed