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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00406003
First received: November 30, 2006
Last updated: May 31, 2012
Last verified: February 2011

November 30, 2006
May 31, 2012
March 2006
April 2006   (final data collection date for primary outcome measure)
To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects
Same as current
Complete list of historical versions of study NCT00406003 on ClinicalTrials.gov Archive Site
To describe Safety profile of healthy subjects when dosed with paroxetine controlled release
Same as current
Not Provided
Not Provided
 
Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pharmacokinetics
  • Depressive Disorder
Drug: Paroxetine controlled Release 12.5mg, 25mg and37.5mg
Other Names:
  • Paroxetine controlled Release 12.5mg
  • 25mg and37.5mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
19 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00406003
PCR104074
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP