Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects
NCT ID: NCT00406003
Last Updated: 2017-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2006-03-24
2006-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Subjects receiving treatment sequence ABC
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.
Paroxetine controlled release tablet
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.
Subjects receiving treatment sequence BAC
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.
Paroxetine controlled release tablet
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.
Subjects receiving treatment sequence CBA
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.
Paroxetine controlled release tablet
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.
Subjects receiving treatment sequence BCA
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.
Paroxetine controlled release tablet
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.
Subjects receiving treatment sequence CAB
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.
Paroxetine controlled release tablet
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.
Subjects receiving treatment sequence ACB
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.
Paroxetine controlled release tablet
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.
Interventions
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Paroxetine controlled release tablet
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.
Eligibility Criteria
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Inclusion Criteria
* 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
19 Years
45 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Beijing, , China
Countries
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Other Identifiers
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PCR104074
Identifier Type: -
Identifier Source: org_study_id