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

NCT03504475 | Completed Phase 1

• 1 other identifier: WS-CP-06-201709-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder; Obsessive-Compulsive Disorder; Panic Disorder; Social Anxiety Disorder; Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Paroxetine Hydrochloride Tablet

EXPERIMENTAL

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

Paxil®

ACTIVE COMPARATOR

During the study session, healthy subjects will be administered a single dose of Paxil® 20mg under Fasting and Fed conditions.

Drug: Paxil® 20 mg

Interventions

Paroxetine Hydrochloride Tablet 20 mg DRUG

A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.

Paroxetine Hydrochloride Tablet

Paxil® 20 mg DRUG

Paxil® Tablet 20 mg will be used as a comparator drug for the bioequivalence study, manufactured by GlaxoSmithKline（Distributed by: Apotex Corp.）.

Also known as: Paroxetine Hydrochloride Tablet 20 mg

Paxil®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are fully informed and voluntarily consent to participate in this study.
• Healthy adult volunteers of ≥18 years old and ≤ 65 years old, male or female.
• 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).
• 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.

You may not qualify if:

• Allergy or hypersensitivity to paroxetine or components in the formulation, or have clear history of drug allergies, or have been diagnosed with allergic constitution.
• 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).
• Present of any unstable or recurrent diseases , or diseases that interfere with the process in vivo of the drug.
• History of drug abuse/dependence, drug-taking, or positive urine drug screen at screening.
• 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.
• 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.
• Use of any medication changed the liver enzyme activity within the 28 days prior to the study.
• Use of any medication within 14 days prior to the study.
• 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.
• Volunteer in any other clinical drug study within 90 days prior to the study.
• Blood donation or lost more than 200 mL of blood within 90 days prior to the study.
• History of needlesickness or hematophobia, or cannot tolerate venipuncture.
• 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.
• 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.
• Positive Human chorionic gonadotropin (HCG) results for female, or lactating women.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• Beijing Winsunny Pharmceutical Co.,Ltd.: collaborator

Study Sites (2)

Beijing TongRen Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing TongRen Hospital

Beijing, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Obsessive-Compulsive Disorder; Panic Disorder; Phobia, Social; Generalized Anxiety Disorder

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Anxiety Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiuli Zhao, PhD

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: March 29, 2018
• Primary Completion: April 24, 2018
• Study Completion: June 16, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-05

Locations

CN (2)