Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Intervention: Paroxetine hydrochloride; PAXIL (Paroxetine hydrochloride )
Intervention description: Paroxetine hydrochloride will be administered.; PAXIL will be administered.
Intervention MeSH terms: Paroxetine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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)
Masking description: This is an open-label study.
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Anxiety Disorders; Bioequivalence study; Paroxetine hydrochloride; PAXIL; Fasting condition

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  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).

        Exclusion Criteria:

          -  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).

          -  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.