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

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.