Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03504475
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborator:
Beijing Winsunny Pharmceutical Co.,Ltd.
Information provided by (Responsible Party):
Beijing Tongren Hospital

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE April 20, 2018
Last Update Posted Date December 18, 2018
Actual Study Start Date  ICMJE March 29, 2018
Actual Primary Completion Date April 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
  • Cmax [ Time Frame: Blood samples collected over 96 hour period ]
    Maximum Observed Concentration (of Paroxetine in Plasma)
  • AUC(0-∞) [ Time Frame: Blood samples collected over 96 hour period ]
    Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
  • AUC(0-t) [ Time Frame: Blood samples collected over 96 hour period ]
    Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
  • Cmax [ Time Frame: Blood samples collected over 96 hour period ]
    Maximum Observed Concentration (of Paroxetine in Plasma)
  • AUC0-∞ [ Time Frame: Blood samples collected over 96 hour period ]
    Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
  • AUC0-t [ Time Frame: Blood samples collected over 96 hour period ]
    Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Change History Complete list of historical versions of study NCT03504475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Major Depressive Disorder
  • Obsessive-Compulsive Disorder
  • Panic Disorder
  • Social Anxiety Disorder
  • Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: Paroxetine Hydrochloride Tablet 20 mg
    A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.
  • 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 Name: Paroxetine Hydrochloride Tablet 20 mg
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Paroxetine Hydrochloride Tablet 20 mg
  • Active Comparator: Paxil®
    During the study session, healthy subjects will be administered a single dose of Paxil® 20mg under Fasting and Fed conditions.
    Intervention: Drug: Paxil® 20 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2018)
53
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2018)
52
Actual Study Completion Date  ICMJE June 16, 2018
Actual Primary Completion Date April 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03504475
Other Study ID Numbers  ICMJE WS-CP-06-201709-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Tongren Hospital
Study Sponsor  ICMJE Beijing Tongren Hospital
Collaborators  ICMJE Beijing Winsunny Pharmceutical Co.,Ltd.
Investigators  ICMJE
Principal Investigator: Xiuli Zhao, PhD Beijing Tongren Hospital
PRS Account Beijing Tongren Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP