A Phase 1 interventional study of Paroxetine 12.5 milligrams tablet and Paroxetine 25 milligrams tablet in Depressive Disorder, sponsored by GlaxoSmithKline. Completed at 1 site in Japan. Open to male participants aged 20 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Other
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.
This clinical trial is to characterize the pharmacokinetic profile after single oral doses of the proposed final market tablet formulations of paroxetine CR in Japan (the 12.5mg and 25mg tablets), at the dose levels of 12.5, 25 and 50mg in the healthy male Japanese volunteers. Treatment sequence of the 3 dose levels in each subject is randomized.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 18 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
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Exclusion Criteria:
Eligible subjects will be randomized in sequence A/B/C and will receive A: single tablet of paroxetine 12.5 milligrams, B: single tablet of paroxetine 25 milligrams and C: two tablets of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet · Drug: Paroxetine 25 milligrams tablet · Drug: Paroxetine 50 milligrams tablet
Eligible subjects will be randomized in sequence A/C/B and will receive A: single tablet of paroxetine 12.5 milligrams, C: two tablets of paroxetine 25 milligrams and B: single tablet of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet · Drug: Paroxetine 25 milligrams tablet · Drug: Paroxetine 50 milligrams tablet
Eligible subjects will be randomized in sequence B/A/C and will receive B: single tablet of paroxetine 25 milligrams, A: single tablet of paroxetine 12.5 milligrams and C: two tablets of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet · Drug: Paroxetine 25 milligrams tablet · Drug: Paroxetine 50 milligrams tablet
Eligible subjects will be randomized in sequence B/C/A and will receive B: single tablet of paroxetine 25 milligrams, C: two tablets of paroxetine 25 milligrams and A: single tablet of paroxetine 12.5 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet · Drug: Paroxetine 25 milligrams tablet · Drug: Paroxetine 50 milligrams tablet
Eligible subjects will be randomized in sequence C/A/B and will receive C: two tablets of paroxetine 25 milligrams, A: single tablet of paroxetine 12.5 milligrams and B: single tablet of paroxetine 25 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet · Drug: Paroxetine 25 milligrams tablet · Drug: Paroxetine 50 milligrams tablet
Eligible subjects will be randomized in sequence C/B/A and will receive C: two tablets of paroxetine 25 milligrams, B: single tablet of paroxetine 25 milligrams and A: single tablet of paroxetine 12.5 milligrams administered orally in the morning. Subjects will be fasting since 10 hours before dosing in each period.
Drug: Paroxetine 12.5 milligrams tablet · Drug: Paroxetine 25 milligrams tablet · Drug: Paroxetine 50 milligrams tablet
Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.
Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.
Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.
Pharmacokinetic parameters of plasma paroxetine after single doses of paroxetine CR at 12.5mg, 25mg and 50mg in healthy Japanese male volunteers
Time frame: up to 120 hours after a single dose in all dosing sessions
Safety and tolerability after single doses of paroxetine CR at 12.5mg, 25mg and 50mg in healthy Japanese male volunteers
Time frame: up to 120 hours after a single dose in all dosing sessions
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline