Depressive DisorderPhase 1NCT00938184
Single Dose Study of Controlled-Release Paroxetine Tablets in Healthy Japanese Male Subjects
A Phase 1 study testing Paroxetine 12.5 milligrams tablet, Paroxetine 25 milligrams tablet and Paroxetine 50 milligrams tablet in people with Depressive Disorder, run by GlaxoSmithKline at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Paroxetine 12.5 milligrams tablet, Paroxetine 25 milligrams tablet and Paroxetine 50 milligrams tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- 14 Jul 2009to 2 Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese adult males between 20 and 64 years of age inclusive
- BMI 18.50 or higher and < 25.00 kg/m2, and bodyweight 50 kg or higher
- Non-smokers
- AST, ALT, ALP, gamma-GTP and total-bilirubin are below the upper limit of normal range
- QTc(B) interval <450 msec
- Able to attend all visits and complete the study
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Who cannot join
- Any clinically relevant abnormality on the screening physical examination, vital signs, 12-lead ECG and/or clinical laboratory tests
- Medical history that is not considered as eligible for inclusion in this study by the investigator
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones)
- History of psychiatric disorder or suicide attempts or behaviours
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- History of sensitivity to any of the paroxetine formulations, or components thereof
Show all 17Show fewer
- Positive for urine drug screening
- Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device
- Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first dose of study medication
- History of drug or other allergy, or idiosyncrasy, excluding a pollen allergy without current symptoms
- History of drug abuse, or current conditions of drug abuse or alcoholism
- History of regular alcohol consumption exceeding, on average, 14 drinks/week (1 drink = 150 mL of wine or 350 mL of beer or 45 mL of 80 proof distilled spirits) within 6 months of screening
- Use of prescription or no-prescription drugs, including vitamins, crude drug, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication
- Unwillingness or inability to follow the procedures outlined in the protocol
- Consumption of grapefruit or grapefruit-containing products from 7 days prior to the first dose of study medication
- Positive for syphilis, HIV antibody and antigen, Hepatitis B surface antigen, Hepatitis C antibody or HTLV-1 antibody
- Donation of blood in excess of 400mL within the previous 4 months or 200mL within the previous 1 month to the first dose of study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Doses of the Controlled-release Paroxetine Tablets at the Dose Levels of 12.5, 25 and 50mg in Healthy Japanese Male Subjects
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.
Read the detailed description
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.
- Conditions
- Depressive Disorder
- Being tested
- Paroxetine 12.5 milligrams tablet, Paroxetine 25 milligrams tablet, Paroxetine 50 milligrams tablet
- Keywords
- tolerance, single dose, paroxetine, controlled-release tablet, safety, pharmacokinetics, Japanese healthy male subjects
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paroxetine 12.5 milligrams tabletDrug
Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.
Paroxetine 25 milligrams tabletDrug
Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.
Paroxetine 50 milligrams tabletDrug
Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence A/B/C | Experimental | 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. Receives: Drug: Paroxetine 12.5 milligrams tablet; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet |
| Treatment sequence A/C/B | Experimental | 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. Receives: Drug: Paroxetine 12.5 milligrams tablet; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet |
| Treatment sequence B/A/C | Experimental | 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. Receives: Drug: Paroxetine 12.5 milligrams tablet; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet |
| Treatment sequence B/C/A | Experimental | 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. Receives: Drug: Paroxetine 12.5 milligrams tablet; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet |
| Treatment sequence C/A/B | Experimental | 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. Receives: Drug: Paroxetine 12.5 milligrams tablet; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet |
| Treatment sequence C/B/A | Experimental | 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. Receives: Drug: Paroxetine 12.5 milligrams tablet; Drug: Paroxetine 25 milligrams tablet; Drug: Paroxetine 50 milligrams tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of plasma paroxetine after single doses of paroxetine CR at 12.5mg, 25mg and 50mg in healthy Japanese male volunteers
Measured: up to 120 hours after a single dose in all dosing sessions
Secondary outcomes (1)
Safety and tolerability after single doses of paroxetine CR at 12.5mg, 25mg and 50mg in healthy Japanese male volunteers
Measured: up to 120 hours after a single dose in all dosing sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study start14 Jul 2009
- Primary completion2 Sep 2009
- Study completion2 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938184
- Sponsor's protocol ID
- 112811
- Status last verified
- Jun 2018
- First submitted
- 9 Jul 2009
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Doses of the Controlled-release Paroxetine Tablets at the Dose Levels of 12.5, 25 and 50mg in Healthy Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT00938184
- Acronym / sponsor ID
- 112811
- Conditions
- Depressive Disorder
- Keywords
- tolerance, single dose, paroxetine, controlled-release tablet, safety, pharmacokinetics, Japanese healthy male subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2009 (actual)
- Primary completion
- 2 Sep 2009 (actual)
- Study completion
- 2 Sep 2009 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence A/B/C | Experimental | Drug: Paroxetine 12.5 milligrams tablet, Drug: Paroxetine 25 milligrams tablet, Drug: Paroxetine 50 milligrams tabletEligible 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. |
| Treatment sequence A/C/B | Experimental | Drug: Paroxetine 12.5 milligrams tablet, Drug: Paroxetine 25 milligrams tablet, Drug: Paroxetine 50 milligrams tabletEligible 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. |
| Treatment sequence B/A/C | Experimental | Drug: Paroxetine 12.5 milligrams tablet, Drug: Paroxetine 25 milligrams tablet, Drug: Paroxetine 50 milligrams tabletEligible 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. |
| Treatment sequence B/C/A | Experimental | Drug: Paroxetine 12.5 milligrams tablet, Drug: Paroxetine 25 milligrams tablet, Drug: Paroxetine 50 milligrams tabletEligible 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. |
| Treatment sequence C/A/B | Experimental | Drug: Paroxetine 12.5 milligrams tablet, Drug: Paroxetine 25 milligrams tablet, Drug: Paroxetine 50 milligrams tabletEligible 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. |
| Treatment sequence C/B/A | Experimental | Drug: Paroxetine 12.5 milligrams tablet, Drug: Paroxetine 25 milligrams tablet, Drug: Paroxetine 50 milligrams tabletEligible 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. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy Japanese adult males between 20 and 64 years of age inclusive
- BMI 18.50 or higher and < 25.00 kg/m2, and bodyweight 50 kg or higher
- Non-smokers
- AST, ALT, ALP, gamma-GTP and total-bilirubin are below the upper limit of normal range
- QTc(B) interval <450 msec
Key exclusion criteria (17 listed)
- Any clinically relevant abnormality on the screening physical examination, vital signs, 12-lead ECG and/or clinical laboratory tests
- Medical history that is not considered as eligible for inclusion in this study by the investigator
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones)
- History of psychiatric disorder or suicide attempts or behaviours
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paroxetine 12.5 milligrams tabletSingle dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally. | Drug | Treatment sequence A/B/C, Treatment sequence A/C/B, Treatment sequence B/A/C, Treatment sequence B/C/A, Treatment sequence C/A/B, Treatment sequence C/B/A |
| Paroxetine 25 milligrams tabletSingle dose of paroxetine 25 milligrams controlled release tablet will be administered orally. | Drug | Treatment sequence A/B/C, Treatment sequence A/C/B, Treatment sequence B/A/C, Treatment sequence B/C/A, Treatment sequence C/A/B, Treatment sequence C/B/A |
| Paroxetine 50 milligrams tabletSingle dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally. | Drug | Treatment sequence A/B/C, Treatment sequence A/C/B, Treatment sequence B/A/C, Treatment sequence B/C/A, Treatment sequence C/A/B, Treatment sequence C/B/A |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Results for study 112811 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Depressive Disorder
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Active, not recruitingPhase 1
Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder
Major Depressive Disorder
Active, not recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Depression, MDD
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paroxetine 12.5 milligrams tablet, Paroxetine 25 milligrams tablet and Paroxetine 50 milligrams tablet in people with Depressive Disorder, run by GlaxoSmithKline at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.