Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Generalized Anxiety Disorder; Major Depressive Disorder; Social Anxiety Disorder; Panic Disorder
• Intervention / Treatment: Drug: Paroxetine Hydrochloride Tablet 20 mg; Drug: Paxil® 20 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tongren Hospital
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paroxetine Hydrochloride Tablet; During the study session, healthy subjects will be administered a single dose of Paroxetine Hydrochloride Tablet 20mg under Fasting and Fed conditions.	Drug: Paroxetine Hydrochloride Tablet 20 mg; A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.
Active Comparator: Paxil®; During the study session, healthy subjects will be administered a single dose of Paxil® 20mg under Fasting and Fed conditions.	Drug: Paxil® 20 mg; Paxil® Tablet 20 mg will be used as a comparator drug for the bioequivalence study, manufactured by GlaxoSmithKline（Distributed by: Apotex Corp.）.; Other Names: Paroxetine Hydrochloride Tablet 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum Observed Concentration (of Paroxetine in Plasma)	Blood samples collected over 96 hour period
AUC(0-∞)	Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	Blood samples collected over 96 hour period
AUC(0-t)	Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	Blood samples collected over 96 hour period

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Collaborators: Beijing Winsunny Pharmceutical Co.,Ltd.
• Investigators: Principal Investigator: Xiuli Zhao, PhD, Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): April 24, 2018
• Study Completion (Actual): June 16, 2018

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Phobic Disorders; Depressive Disorder; Disease; Obsessive-Compulsive Disorder; Anxiety Disorders; Depressive Disorder, Major; Phobia, Social; Panic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: WS-CP-06-201709-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No