Bioequivalence Study in Healthy Subjects

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Candesartan cilexetil

• Registration Number: NCT00844324
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Study Start: 2009-03
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-06
• Last Update Posted: 2010-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Candesartan cilexetil	Candesartan cilexetil 1mg/mL
B	Candesartan cilexetil	Candesartan cilexetil 1.6mg/mL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety variables (adverse events, ECG, vital signs, safety laboratory)	During the whole treatment period

Trial Locations

Locations (1)

Research Site; 🇬🇧 Harrow, United Kingdom