Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison

AstraZeneca63 enrolled

Overview

This study will compare the tolerability of Quetiapine Fumarate immediate release formulation and Quetiapine Fumarate extended release formulation during initial dose escalation in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Quetiapine FumarateDRUG

Tablet, Oral, once daily

Quetiapine FumarateDRUG

Tablet, Oral, once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * Weight of at least 50 kg Exclusion Criteria: * A history or presence of neurological, hematological, psychiatric, gastrointestinal, hepatic, pulmonary, or renal disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs * Positive test results for alcohol or drugs of abuse * Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody

Locations (1)

Research Site

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) 1 hour post dose at Day 1

Time frame: 1 hour after dose administration at the first dosing day (i.e. Day 1) of each period

Area under the VAS-time curve

Time frame: Calculated daily from the 13 assessments for 5 days

Secondary Outcomes

Pharmacodynamic relationship between maximum VAS and PK concentration

Time frame: On last day of period (Day 5)

Data from ClinicalTrials.gov

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