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Completed

NCT Number: NCT00406003

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

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

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Key information

Conditions

Depressive Disorder Mental Disorders Mood Disorders

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Beijing, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paroxetine controlled release tablet

Drug

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 outcomes

  1. 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 outcomes

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

    Time frame: Up to 32 days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Dec 4, 2006
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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