Anxiety DisordersPhase 1NCT04311463

Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants

A Phase 1 study testing Paroxetine hydrochloride and PAXIL (Paroxetine hydrochloride ) in people with Anxiety Disorders, run by GlaxoSmithKline at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety Disorders
What is being tested?: Paroxetine hydrochloride and PAXIL (Paroxetine hydrochloride )
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteMexico
Study dates: 9 Dec 2020to 2 Jan 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male and female participants aged between 18 and 55 years.
Participant is a light smoker (someone who smokes 9 or less cigarettes per day) or non- or an ex-smoker (someone who completely stopped smoking for at least 6 months before day 1 of this study).
With a weight greater than or equal to (>=)50.00 kilograms (kg).
With a body mass index (BMI) >=18.5 kilograms per meter square (kg/m^2) and less than or equal to (<=)27.0 kg/m^2.
Found healthy according to the clinical laboratory results and physical examination (performed within 90 days prior to the dosing on period -1).
Have a normal 12 lead electrocardiogram (ECG) and vital signs.

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Have laboratory test results within the laboratory's stated normal range; if not within this range, they must lack of no clinical significance as judged by the principal investigator (PI) or responsible physician.
Willing to avoid sexual contact or use an acceptable contraceptive method during the study including the washout period (for females). In case of male participants, they should avoid sexual contact or use a latex or synthetic condom each time they have sex with a woman while taking Paroxetine and during 7 days after the end of the study.
If study participant is a female and is of child bearing potential, practicing an acceptable method of birth control for the duration of the study as judged by the investigators, like combined short acting (estrogen and progestogen containing) hormonal contraception for example (e.g.) oral, intravaginal, and progestogen-only hormonal contraception e.g. oral, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), condoms, foams, jellies and diaphragm or abstinence or if study participant is a female and is postmenopausal for at-least 1 year or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the study participant).
Have a negative test for active Coronavirus Disease-2019 (COVID-19), within 72 hours prior to the first period check-in. The testing should be done using a molecular (Real time-Polymerase Chain Reaction [RT-PCR]) approved by the country regulatory authorities.
Participant is able to communicate effectively and voluntarily agreed to participate in this study by signing written informed consent after being informed sufficiently about study aspects like objectives, study procedures, characteristics of the investigational drug, expected adverse events.
Participant willing to adhere to protocol requirements as described in informed consent (written) approved by research ethics committee/research committee (REC/RC).

Who cannot join

If participants age is less than 18 or older than 55 years.
Have any history of allergy or hypersensitivity to Paroxetine or derivatives to any of its metabolites/derivatives or related drugs or excipients.
Have a positive test result for hepatitis B surface antigen (HBs Ag) or hepatitis C virus antibody (HCV Ab) or human immune deficiency virus (HIV) antibodies (types 1 and 2) or venereal disease research laboratory (VDRL).
Participants with symptoms suggestive of active COVID-19 infection (that is, fever, cough, respiratory difficulties) within 14 days of inpatient admission.
Participants with known COVID-19 positive contact (meaning if the participant has been living, providing care, being within 1.5 meters for at least 15 min or having exposure to respiratory secretions with/to a person who has COVID-19) within the past 14 days prior to the first period check-in. Study drug is contraindicated for medical reasons to the participants.
Have any history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, seizures, endocrine, dermatological, neurological or psychiatric disease or disorder (e.g. participants with uncontrolled hypertension, pheochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute confusional states).

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Presence of significant gastrointestinal, hepatic or kidney disease, or surgery or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects or participants with a history of gastrointestinal disorder or surgery which may affect the absorption of investigational drug.
Have a history of alcohol abuse or drug abuse during the last 1 year prior to period -1 dosing.
Have a history of smoking >=10 cigarettes per day during the last 6 months prior to period -1 dosing.
Have history or presence of cancer.
Have any history of gastrointestinal ulcers/intestinal bleeding.
Have history of difficulty for donating blood.
Have clinically significant abnormal laboratory tests results.
Have a systolic blood pressure less than (<)90 or greater than (>)140 millimeters of mercury (mmHg) or diastolic blood pressure is <60 or >90 mmHg.
Have a pulse rate <60 beats/minute or >100 beats/minute (lower range of pulse range will be accepted up to 45 beats/minute in case of athlete).
Have used any prescribed medication during the last 14 days preceding the first dosing, or use over-the-counter (OTC), medicinal or herbal products during the last 7 days or use medicinal enzyme inhibitors / inducers during last 30 days preceding the first dosing.
Have participated in a drug research study or donated blood within the last 3 months.
Have a positive result for drugs of abuse test (cannabinoids [marijuana/tetrahydrocannabinol-(THC)], cocaine, opiates/morphine, amphetamine, methamphetamine and benzodiazepines] performed during screening.
Female participant, who is currently breast feeding or a who is pregnant or who is likely to become pregnant during the study.
Female participant has a positive pregnancy test results.
Unwillingness or inability to comply with the instructions on the lifestyle.
If the PI considers, for any reason, that the volunteer is not a suitable candidate to receive the study drug.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

GSK Investigational Site
Monterrey, Nuevo León, 66260

Other trials in Mexico

About this study

Official title: An Oral Single-dose, Randomized, Balanced, Open-label, Two-sequence, Two-treatment, Two-period, Crossover Bioequivalence Study of Paroxetine Tablets 20 mg of GlaxoSmithKline Pharmaceuticals S.A, With That of PAXIL (Paroxetine) Tablets 20 mg of GlaxoSmithKline México S.A. de C.V., in Healthy Adult Male and Female Subjects Under Fasting Conditions

This study will be conducted to evaluate and compare the single oral dose bioavailability of Paroxetine manufactured by GlaxoSmithKline (GSK) Pharmaceuticals S.A. for GlaxoSmithKline México, S.A. de C.V. with that of PAXIL® (Paroxetine) of GlaxoSmithKline, México, S.A. de C.V. in healthy, adult, male and female participants under fasting conditions. Maximum 38 participants will be randomized and dosed. The expected duration of this study will be 12 days including 7 days of washout period in-between each dosing. PAXIL is a registered trademark of GSK group of companies.

Conditions: Anxiety Disorders
Being tested: Paroxetine hydrochloride, PAXIL (Paroxetine hydrochloride )
Keywords: Anxiety Disorders, Bioequivalence study, Paroxetine hydrochloride, PAXIL, Fasting condition
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Paroxetine hydrochlorideDrug
Paroxetine hydrochloride will be administered.
PAXIL (Paroxetine hydrochloride )Drug
PAXIL will be administered.

Study groups in NCT04311463
Study group	Role	What they receive
Paroxetine hydrochloride followed by PAXIL	Experimental	Not described Receives: Drug: Paroxetine hydrochloride; Drug: PAXIL (Paroxetine hydrochloride )
PAXIL followed by paroxetine hydrochloride	Experimental	Not described Receives: Drug: Paroxetine hydrochloride; Drug: PAXIL (Paroxetine hydrochloride )

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Paroxetine
Blood samples were collected at indicated time points for the analysis of Cmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Measured: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUC[0-t]) of Paroxetine
Blood samples were collected at indicated time points for the analysis of AUC(0-t) of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Measured: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Paroxetine
Blood samples were collected at indicated time points for the analysis of AUC(0-inf) of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Measured: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Percentage of AUC (0 to Infinity) Obtained by Extrapolation (%AUCex) of Paroxetine
Blood samples were collected at indicated time points for the analysis of %AUCex of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Measured: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Time of the Maximum Measured Plasma Concentration (Tmax) of Paroxetine
Blood samples were collected at indicated time points for the analysis of Tmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Measured: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Elimination Half-life (t1/2) of Paroxetine
Blood samples were collected at indicated time points for the analysis of t1/2 of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Measured: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Terminal Elimination Rate Constant (Kel) of Paroxetine
Blood samples were collected at indicated time points for the analysis of Kel of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Measured: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose

Secondary outcomes (2)

Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence that may occur in a research participant during clinical research phase of a drug or vaccine but which does not necessarily has a causal relationship with this. SAE is defined as any medical occurrence that, at any dose, put participants's life in risk or results in death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent significant disability/incapacity, is a congenital anomaly/birth defect and other important medical events according to medical or scientific judgement.
Measured: Up to 25 days
Number of Participants With Abnormal Vital Signs
Systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate, respiration rate and body temperature were measured in semi-supine position after 5 minutes rest. The clinically acceptable range included; SBP: 85 millimeters of mercury (mmHg) to 160 mmHg; DBP: 45 mmHg to 100 mmHg; pulse rate: 40 beats per minute to 110 beats per minute; respiration rate: 8 breaths per minute to 20 breaths per minute; body temperature: 35.5 degrees Celsius to 37.8 degrees Celsius. Number of participants with any abnormality in vital signs are presented. Data is presented treatment wise.
Measured: Up to 25 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 20202 Jan 2021

First posted17 Mar 2020
Study start9 Dec 2020
Primary completion2 Jan 2021
Study completion2 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anxiety DisordersStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: A single-dose, randomized, balanced, open-label, two-sequence, two-treatment, two-period, crossover bioequivalence study under fasting condition.
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04311463
Sponsor's protocol ID: 212969
Status last verified: Dec 2021
First submitted: 16 Mar 2020
Last updated: 20 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Oral Single-dose, Randomized, Balanced, Open-label, Two-sequence, Two-treatment, Two-period, Crossover Bioequivalence Study of Paroxetine Tablets 20 mg of GlaxoSmithKline Pharmaceuticals S.A, With That of PAXIL (Paroxetine) Tablets 20 mg of GlaxoSmithKline México S.A. de C.V., in Healthy Adult Male and Female Subjects Under Fasting Conditions
ClinicalTrials.gov ID: NCT04311463
Acronym / sponsor ID: 212969
Conditions: Anxiety Disorders
Keywords: Anxiety Disorders, Bioequivalence study, Paroxetine hydrochloride, PAXIL, Fasting condition
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 9 Dec 2020 (actual)
Primary completion: 2 Jan 2021 (actual)
Study completion: 2 Jan 2021 (actual)
First posted: 17 Mar 2020 (actual)
Results: Posted 20 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: A single-dose, randomized, balanced, open-label, two-sequence, two-treatment, two-period, crossover bioequivalence study under fasting condition.

Arm	Type	Receives
Paroxetine hydrochloride followed by PAXIL	Experimental	Drug: Paroxetine hydrochloride, Drug: PAXIL (Paroxetine hydrochloride )
PAXIL followed by paroxetine hydrochloride	Experimental	Drug: Paroxetine hydrochloride, Drug: PAXIL (Paroxetine hydrochloride )

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Healthy adult male and female participants aged between 18 and 55 years.
Participant is a light smoker (someone who smokes 9 or less cigarettes per day) or non- or an ex-smoker (someone who completely stopped smoking for at least 6 months before day 1 of this study).
With a weight greater than or equal to (>=)50.00 kilograms (kg).
With a body mass index (BMI) >=18.5 kilograms per meter square (kg/m^2) and less than or equal to (<=)27.0 kg/m^2.
Found healthy according to the clinical laboratory results and physical examination (performed within 90 days prior to the dosing on period -1).

Key exclusion criteria (22 listed)

If participants age is less than 18 or older than 55 years.
Have any history of allergy or hypersensitivity to Paroxetine or derivatives to any of its metabolites/derivatives or related drugs or excipients.
Have a positive test result for hepatitis B surface antigen (HBs Ag) or hepatitis C virus antibody (HCV Ab) or human immune deficiency virus (HIV) antibodies (types 1 and 2) or venereal disease research laboratory (VDRL).
Participants with symptoms suggestive of active COVID-19 infection (that is, fever, cough, respiratory difficulties) within 14 days of inpatient admission.
Participants with known COVID-19 positive contact (meaning if the participant has been living, providing care, being within 1.5 meters for at least 15 min or having exposure to respiratory secretions with/to a person who has COVID-19) within the past 14 days prior to the first period check-in. Study drug is contraindicated for medical reasons to the participants.

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 hydrochlorideParoxetine hydrochloride will be administered.	Drug	PAXIL followed by paroxetine hydrochloride, Paroxetine hydrochloride followed by PAXIL
PAXIL (Paroxetine hydrochloride )PAXIL will be administered.	Drug	PAXIL followed by paroxetine hydrochloride, Paroxetine hydrochloride followed by PAXIL

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Paroxetine
Time frame: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Blood samples were collected at indicated time points for the analysis of Cmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUC[0-t]) of Paroxetine
Time frame: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Blood samples were collected at indicated time points for the analysis of AUC(0-t) of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Paroxetine
Time frame: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Blood samples were collected at indicated time points for the analysis of AUC(0-inf) of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Percentage of AUC (0 to Infinity) Obtained by Extrapolation (%AUCex) of Paroxetine
Time frame: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Blood samples were collected at indicated time points for the analysis of %AUCex of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Time of the Maximum Measured Plasma Concentration (Tmax) of Paroxetine
Time frame: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Blood samples were collected at indicated time points for the analysis of Tmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Elimination Half-life (t1/2) of Paroxetine
Time frame: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Blood samples were collected at indicated time points for the analysis of t1/2 of Paroxetine. PK parameters were analyzed using non-compartmental analysis.
Terminal Elimination Rate Constant (Kel) of Paroxetine
Time frame: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Blood samples were collected at indicated time points for the analysis of Kel of Paroxetine. PK parameters were analyzed using non-compartmental analysis.

2 secondary outcomes

Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 25 days
Number of Participants With Abnormal Vital Signs
Time frame: Up to 25 days

Results and safety

Results posted to the registry on 20 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paroxetine 20 mg (A) Followed by Paxil 20 mg (B)	19	18
Paxil 20 mg (B) Followed by Paroxetine 20 mg (A)	19	19

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Paroxetine

Time frame: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose. Mean (Standard Deviation). Unit: Nanograms per milliliter

Measure	Paroxetine 20 mg (Test A) n = 31	Paroxetine 20 mg (Reference B) n = 31
Value	8.39 (5.872)	8.83 (6.554)

Population analysed: Pharmacokinetic (PK) analysis set included participants who completed both period of the study as per protocol criteria. Only those participants with data available at the specified data points were analyzed.

Primary outcome: Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUC[0-t]) of Paroxetine

Time frame: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose. Mean (Standard Deviation). Unit: Hour*nanograms per milliliter

Measure	Paroxetine 20 mg (Test A) n = 31	Paroxetine 20 mg (Reference B) n = 30
Value	128.876 (118.288)	150.549 (137.497)

Population analysed: PK analysis set. Only those participants with data available at the specified data points were analyzed.

Primary outcome: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Paroxetine

Measure	Paroxetine 20 mg (Test A) n = 31	Paroxetine 20 mg (Reference B) n = 30
Value	142.482 (149.098)	160.143 (149.403)

Population analysed: PK analysis set. Only those participants with data available at the specified data points were analyzed.

Primary outcome: Percentage of AUC (0 to Infinity) Obtained by Extrapolation (%AUCex) of Paroxetine

Time frame: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose. Mean (Standard Deviation). Unit: Percentage of AUCex

Measure	Paroxetine 20 mg (Test A) n = 31	Paroxetine 20 mg (Reference B) n = 30
Value	7.95 (8.053)	7.05 (7.499)

Population analysed: PK analysis set. Only those participants with data available at the specified data points were analyzed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality, non-serious AEs and Serious AEs were collected up to 25 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paroxetine 20 mg (Test A)	0 of 38 (0%)	7 of 38 (18.4%)	0 of 38
Paroxetine 20 mg (Reference B)	0 of 38 (0%)	7 of 38 (18.4%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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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 hydrochloride and PAXIL (Paroxetine hydrochloride ) in people with Anxiety Disorders, run by GlaxoSmithKline at 1 site in Mexico.

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 12 inclusion and 22 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 20 Jan 2022. 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 Mexico. 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?

Yes. Results are posted in the registry (first posted 20 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Observed Plasma Concentration (Cmax) of Paroxetine (time frame: Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04311463.

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 20 Jan 2022.