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Bioequivalence Study in Healthy Subjects

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Candesartan cilexetil (Drug); Candesartan cilexetil (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
James Hainer, MD, Study Director, Affiliation: AstraZeneca
Klaus Francke, Dr, Principal Investigator, Affiliation: Parexel

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: PK (Candesartan cilexetil)

Secondary outcome: Safety variables (adverse events, ECG, vital signs, safety laboratory)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Research Site, Harrow, United Kingdom
Additional Information

Starting date: March 2009
Last updated: December 6, 2010

Page last updated: August 20, 2015

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