Guanfacine Immediate-release Electrocardiogram Results (QTc) Study

Shire

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: immediate release guanfacine hydrochloride; Drug: moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00672984

SPD503-112

Details and patient eligibility

About

To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females

Enrollment: 83 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy Normal Subjects

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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83 participants in 3 patient groups, including a placebo group

Immediate-release Guanfacine HCl

Experimental group

Treatment:

Drug: immediate release guanfacine hydrochloride

Moxifloxacin HCl

Active Comparator group

Treatment:

Drug: moxifloxacin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo