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Bioavailability Study of Candesartan Cilexetil 16mg Tablet Under Fasting Conditions

NCT02006602 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-03-08

No results posted yet for this study

Summary

This will be an open-label, randomized, single dose, two-way crossover study. Each subject will participate in both treatment periods and will receive single oral doses of candesartan cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™); the treatment periods will be separated by a washout period of at least 7 days and no greater than 14 days. This study aims to determine the relative bioavailability of a 16mg test formulation tablet of candesartan cilexetil (GW615775) compared to an 16mg reference tablet of candesartan cilexetil in healthy adult subjects. ATACAND is a registered trademark of the Astra/Zeneca group of companies.

Conditions

Interventions

DRUG

Candesartan cilexetil (GW615775, Test formulation)

Test formulation candesartan cilexetil 16 mg will be supplied as round, biconvex white tablets with PX 16 embossed in one face and scored in the other face.

DRUG

Candesartan cilexetil (Reference treatment)

Reference treatment of candesartan cilexetil 16 mg will be supplied as round, biconvex pink tablets, scored in one face and with embossment in both faces (016 embossment in the plain face and A CH in the scored face).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-12-13
Primary Completion
2014-01-22
Completion
2014-01-22

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 NCT02006602 on ClinicalTrials.gov