Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers
Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers
The objective of this study is to compare the rate and extent of absorption of paroxetine
 hydrochloride 20 mg tablets (test) and Paxil® (reference) administered as 20 mg tablet under
 fed conditions.
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence
 Study with a washout period of 14 days. During each session, the subjects will be
 administered a single dose of 20 mg Paroxetine (one Paroxetine Hydrochloride Tablet 20mg or
 one Paxil® Tablet 20 mg) under Fasting and Fed conditions. Venous blood samples will be
 collected at pre-dose (0 h), and up to 96 h post dose.
Inclusion Criteria:

 1. Subjects are fully informed and voluntarily consent to participate in this study.

 2. Healthy adult volunteers of ≥18 years old and ≤ 65 years old, male or female.

 3. Body weight ≥ 50.0 kg for male and 45.0 kg for female , and body mass index (BMI)
 ranges from 19.0 to 28.0 kg/m2(including).

 4. The results of physical examination, vital signs examination, clinical laboratory
 examination (blood routine, urine routine, blood biochemistry), 12-lead
 electrocardiogram (ECG), chest radiograph were normal or no clinical significant.

 Exclusion Criteria:

 1. Allergy or hypersensitivity to paroxetine or components in the formulation, or have
 clear history of drug allergies, or have been diagnosed with allergic constitution.

 2. History of any diseases which could interfere with the clinical safety or the process
 in vivo of the drug, such as liver, kidney, cardiovascular, tuberculosis, epilepsy,
 asthma, diabetes or glaucoma disease, especially the endocrine disease,
 gastrointestinal disease, gastrointestinal surgery, or unresolved gastrointestinal
 symptoms (such as diarrhea, vomiting).

 3. Present of any unstable or recurrent diseases , or diseases that interfere with the
 process in vivo of the drug.

 4. History of drug abuse/dependence, drug-taking, or positive urine drug screen at
 screening.

 5. Significant alcohol abuse within 2 years ( more than two units of alcohol per day,
 drink at least 14 units of alcohol per week: 1 unit = 285 mL of beer or 120 mL of
 white spirit or 25 mL of spirit or 100 mL of wine) ,or positive alcohol exhalation
 test at screening.

 6. Smoking within 1 year (more than 5 cigarettes per day), or could not avoid smoking
 during the study period started from signing the informed consent forms.

 7. Use of any medication changed the liver enzyme activity within the 28 days prior to
 the study.

 8. Use of any medication within 14 days prior to the study.

 9. With special diet (including grapefruit and/or xanthine, etc.) or vigorous exercise,
 or other factors that affected the drug absorption/distribution/metabolism/excretion
 within 14 days prior to the study.

 10. Volunteer in any other clinical drug study within 90 days prior to the study.

 11. Blood donation or lost more than 200 mL of blood within 90 days prior to the study.

 12. History of needlesickness or hematophobia, or cannot tolerate venipuncture.

 13. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV)
 antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.

 14. Have the family fertility plan, unwilling or unable to take effective contraceptive
 methods to prevent pregnancy from 30 days before the study until 6 months after the
 end of study.

 15. Positive Human chorionic gonadotropin (HCG) results for female, or lactating women.

 16. Have special diet, cannot control diet and exercise as requested.

 17. Other situations that the researchers considered unsuitable to enroll the subject.