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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Quetiapine Fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00702676

D1443C00033

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

63 participants in 2 patient groups

1

Experimental group

Description:

Quetiapine Fumarate Immediate Release

Treatment:

Drug: Quetiapine Fumarate

Drug: Quetiapine Fumarate

2

Experimental group

Description:

Quetiapine Fumarate Extended Release

Treatment:

Drug: Quetiapine Fumarate

Drug: Quetiapine Fumarate