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

Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406003
• Other study ID #: PCR104074
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2006
• Last updated: September 27, 2017
• Start date: March 24, 2006
• Est. completion date: April 26, 2006

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 26, 2006
• Est. primary completion date: April 26, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	GSK Investigational Site	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects		Up to 32 days
Secondary	To describe Safety profile of healthy subjects when dosed with paroxetine controlled release		Up to 32 days

External Links

•   Results for study PCR104074 can be found on the GSK Clinical Study Register.