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Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects

Primary Purpose

Depressive Disorder

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Paroxetine controlled release tablet

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring BRL029060/Paroxetine CR, pharmacokinetics, safety

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

19-45 years healthy Chinese
Body weight > 50 kg
BMI between 19-25
serological negative for HIV, syphilis and hepatitis B and C
no abnormalities in ECG
Female with negative pregnancy and male has no plan to have a child during and 3 months after the study.

Exclusion criteria:

History of chronic physical/mental disease, current disease and concomitant medication

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Subjects receiving treatment sequence ABC

Subjects receiving treatment sequence BAC

Subjects receiving treatment sequence CBA

Subjects receiving treatment sequence BCA

Subjects receiving treatment sequence CAB

Subjects receiving treatment sequence ACB

Arm Description

Eligible subjects will receive treatment sequence ABC; A= paroxetine 12.5 milligrams, B= paroxetine 25 milligrams, and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.

Eligible subjects will receive treatment sequence BAC; B= paroxetine 25 milligrams, A= paroxetine 12.5 milligrams and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.

Eligible subjects will receive treatment sequence CBA; C= paroxetine 37.5 milligrams, B= paroxetine 25 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.

Eligible subjects will receive treatment sequence BCA; B= paroxetine 25 milligrams, C= paroxetine 37.5 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.

Eligible subjects will receive treatment sequence CAB; C= paroxetine 37.5 milligrams, A= paroxetine 12.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.

Eligible subjects will receive treatment sequence ACB; A= paroxetine 12.5 milligrams, C= paroxetine 37.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.

Outcomes

Primary Outcome Measures

To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects

Secondary Outcome Measures

To describe Safety profile of healthy subjects when dosed with paroxetine controlled release

Full Information

NCT ID

NCT00406003

First Posted

November 30, 2006

Last Updated

September 27, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00406003

Brief Title

Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects

Official Title

A Randomized, Open, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Dosing of Each Enteric-coated Geomatrix Control Release Tablet Strength (12.5, 25, 37.5mg) in Healthy Chinese Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

March 24, 2006 (Actual)

Primary Completion Date

April 26, 2006 (Actual)

Study Completion Date

April 26, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 to 37.5 mg) as well as safety profile

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder

Keywords

BRL029060/Paroxetine CR, pharmacokinetics, safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects receiving treatment sequence ABC

Arm Type

Experimental

Arm Description

Eligible subjects will receive treatment sequence ABC; A= paroxetine 12.5 milligrams, B= paroxetine 25 milligrams, and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.

Arm Title

Subjects receiving treatment sequence BAC

Arm Type

Experimental

Arm Description

Eligible subjects will receive treatment sequence BAC; B= paroxetine 25 milligrams, A= paroxetine 12.5 milligrams and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.

Arm Title

Subjects receiving treatment sequence CBA

Arm Type

Experimental

Arm Description

Eligible subjects will receive treatment sequence CBA; C= paroxetine 37.5 milligrams, B= paroxetine 25 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.

Arm Title

Subjects receiving treatment sequence BCA

Arm Type

Experimental

Arm Description

Eligible subjects will receive treatment sequence BCA; B= paroxetine 25 milligrams, C= paroxetine 37.5 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.

Arm Title

Subjects receiving treatment sequence CAB

Arm Type

Experimental

Arm Description

Eligible subjects will receive treatment sequence CAB; C= paroxetine 37.5 milligrams, A= paroxetine 12.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.

Arm Title

Subjects receiving treatment sequence ACB

Arm Type

Experimental

Arm Description

Eligible subjects will receive treatment sequence ACB; A= paroxetine 12.5 milligrams, C= paroxetine 37.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.

Intervention Type

Drug

Intervention Name(s)

Paroxetine controlled release tablet

Intervention Description

Paroxetine will be given as single dose, controlled release tablet with dosing strengths of 12.5, 25 and 37.5 milligrams in fasted state separated by a wash-out period of 10 days.

Primary Outcome Measure Information:

Title

To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects

Time Frame

Up to 32 days

Secondary Outcome Measure Information:

Title

To describe Safety profile of healthy subjects when dosed with paroxetine controlled release

Time Frame

Up to 32 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 19-45 years healthy Chinese Body weight > 50 kg BMI between 19-25 serological negative for HIV, syphilis and hepatitis B and C no abnormalities in ECG Female with negative pregnancy and male has no plan to have a child during and 3 months after the study. Exclusion criteria: History of chronic physical/mental disease, current disease and concomitant medication

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

Learn more about this trial

Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects

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