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Trial to Assess the Bioavailability of Quetiapine Versus Seroquel® in Subjects With Schizophrenia or Bipolar Disorder

NCT03872596 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-09-02

No results posted yet for this study

Summary

This is a two-part trial.

The primary objective of Part A is to estimate the ratio of geometric means of pharmacokinetic (PK) parameters and their within-subject variability for the 300mg quetiapine tablet formulation A and the 300mg quetiapine tablet formulation B compared to 300mg Seroquel.

The primary objective of Part B is to estimate the ratio of geometric means of PK parameters and their within-subject variability for the selected tablet formulation from Part A of 25mg quetiapine compared to 25mg Seroquel.

Conditions

Interventions

DRUG

Seroquel IR 300mg

Administered during Part A, administered orally BID with water, over 5 days.

DRUG

Seroquel IR 25mg

Administered during Part B, as a single, 25mg dose taken with water.

DRUG

Quetiapine Formulation A 300mg

Administered during Part A, administered orally BID with water, over 5 days.

DRUG

Quetiapine Formulation B 300mg

Administered during Part A, administered orally BID with water, over 5 days.

DRUG

Quetiapine Formulation 25mg

Administered during Part B, as a single, 25mg dose taken with water.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Ernest Roos, M.D. · Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-27
Primary Completion
2019-10-30
Completion
2019-11-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03872596 on ClinicalTrials.gov