Clinical trial NCT03504475: Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers
Official title: An Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study of Paroxetine Hydrochloride 20 mg Tablets and Paxil® Under Fasting Conditions and Under Fed Conditions in Chinese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Obsessive-Compulsive Disorder
Panic Disorder
Social Anxiety Disorder
Generalized Anxiety Disorder
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Winsunny Pharmceutical Co.,Ltd.
First posted: 2018-04-20
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax
timeFrame: Blood samples collected over 96 hour period
measure: AUC(0-∞)
timeFrame: Blood samples collected over 96 hour period
measure: AUC(0-t)
timeFrame: Blood samples collected over 96 hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TongRen Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing TongRen Hospital
Study officials:
affiliation: Beijing Tongren Hospital
name: Xiuli Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References: