Last reviewed · How we verify

NCT00938184

Single Dose Study of Controlled-Release Paroxetine Tablets in Healthy Japanese Male Subjects

Completed Phase 1 Last updated 19 June 2018
What this trial tests

Phase 1 trial testing Paroxetine 12.5 milligrams tablet in Depressive Disorder in 18 participants. Completed in 2 September 2009.

Timeline
14 July 2009
Primary endpoint
2 September 2009
2 September 2009

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeother
Enrollment18
Start date14 July 2009
Primary completion2 September 2009
Estimated completion2 September 2009
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 64, male only, with Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to to assess the pharmacokinetics of paroxetine after single doses of paroxetine CR at the dose levels of 12.5, 25 and 50mg in healthy Japanese male volunteers.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Depressive Disorder

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00938184.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing