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Paxil

Phase 1

Depressive Disorder | Small molecule | Psychiatry |GSK plc|Trials Updated: Aug 4, 2017

Paxil development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Feb 2009

Paxil target and mechanism

ModalitySmall molecule

Also known as Paxil CR, PAXIL (Paroxetine hydrochloride )

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment166

FDA Designations

No designations recorded

Paxil clinical trials

Paxil · 1 trial · 1 indication

Phase 1 1
NCT00749359PAXIL CR Bioequivalence StudyDepressive Disorder
COMPLETED166 Analytics
PHASE1COMPLETED
PAXIL CR Bioequivalence Study
Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Paroxetine blood levels
measured up to 168 hours after a single dose.

Secondary Endpoints

Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs
measured up to 168 hours after a single dose and throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
open label treatmentEXPERIMENTALOn each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1.

Interventions

NameTypeDescription
Paxil CRDRUGPaxil CR 37mg tablet manufactures at two different sites
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Key Inclusion: Healthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG. Key Exclusion: Positive test for drugs or alcohol. Positive for Hepatitis...

Countries:United States
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Frequently asked questions about Paxil

What is Paxil?

Paxil is a small molecule medicine developed by GSK plc for depressive disorder, a condition within psychiatry. It is also known as Paxil CR and paroxetine hydrochloride. Paxil is investigational in the development stage described here, with clinical work recorded at Phase 1 rather than as an approved product.

What is Paxil used for?

Paxil is being studied for depressive disorder. The recorded clinical work in this indication is a Phase 1 bioequivalence study conducted in the United States. Because the development stage listed is Phase 1, Paxil is investigational for depressive disorder and is not described here as an approved treatment.

Who makes Paxil?

Paxil is developed by GSK plc, which trades under the ticker GSK. GSK is the company associated with the Paxil program for depressive disorder, including the Phase 1 bioequivalence study of Paxil CR conducted in the United States.

What phase is Paxil in?

Paxil is in Phase 1 development for depressive disorder. One Phase 1 trial is recorded, and it has completed, with no active trials listed. Paxil is therefore investigational in this program and is not described as FDA approved.

What clinical trials is Paxil in?

Paxil has been studied in the Phase 1 trial NCT00749359, titled PAXIL CR Bioequivalence Study. That trial enrolled 166 participants in the United States, included adults 18 years and older of all sexes, and used healthy volunteers. It is recorded as completed, and no active trials are listed.

Is Paxil the same as Paxil CR or paroxetine hydrochloride?

Yes. Paxil is also known as Paxil CR and as paroxetine hydrochloride. Paxil CR refers to the controlled-release form studied in the Phase 1 bioequivalence trial NCT00749359, and paroxetine hydrochloride is the chemical name for the same small molecule developed by GSK plc.