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Relative Bioavailability Study of Candesartan Cilexetil Under Fasting Conditions

NCT02254447 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-03-12

No results posted yet for this study

Summary

This study will investigate the relative bioavailability of two candidate tablet formulations of 16 milligram (mg) Candesartan cilexetil (GW615775) compared with the reference product ATACAND™ containing 16 mg Candesartan cilexetil in healthy human subjects. This is an open-label, randomized, single dose, three-way crossover, six sequence study enrolling 18 healthy human subjects to ensure at least 14 subjects complete the study as planned. Each subject enrolled will participate in all three treatment periods and will be assigned to one of the six treatment sequences, in accordance with the randomization schedule. The treatment periods will be separated by a washout period of at least 7 days and no more than 14 days between dosing occasions. A follow up visit will be conducted 14-21 days post last dosing. ATACAND is a registered trademark of the AstraZeneca group of companies.

Conditions

Interventions

DRUG

Candesartan Cilexetil in formulation 1

Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration

DRUG

Candesartan Cilexetil in formulation 2

Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration

DRUG

ATACAND

Round, biconvex pink tablets containing Candesartan cilexetil 16 mg for oral administration

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-02
Primary Completion
2015-01-08
Completion
2015-01-08

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02254447 on ClinicalTrials.gov