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

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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

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Obsessive-Compulsive Disorder Panic Disorder Social Anxiety Disorder Generalized Anxiety Disorder Drug: Paroxetine Hydrochloride Tablet 20 mg Drug: Paxil® 20 mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 29, 2018
Actual Primary Completion Date : April 24, 2018
Actual Study Completion Date : June 16, 2018


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 Name: Paroxetine Hydrochloride Tablet 20 mg




Primary Outcome Measures :
  1. Cmax [ Time Frame: Blood samples collected over 96 hour period ]
    Maximum Observed Concentration (of Paroxetine in Plasma)

  2. AUC(0-∞) [ Time Frame: Blood samples collected over 96 hour period ]
    Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504475


Locations
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China, Beijing
Beijing TongRen Hospital
Beijing, Beijing, China, 100730
China
Beijing TongRen Hospital
Beijing, China
Sponsors and Collaborators
Beijing Tongren Hospital
Beijing Winsunny Pharmceutical Co.,Ltd.
Investigators
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Principal Investigator: Xiuli Zhao, PhD Beijing Tongren Hospital

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Responsible Party: Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT03504475     History of Changes
Other Study ID Numbers: WS-CP-06-201709-01
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Depressive Disorder
Depression
Depressive Disorder, Major
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Panic Disorder
Phobia, Social
Pathologic Processes
Mental Disorders
Mood Disorders
Behavioral Symptoms
Personality Disorders
Phobic Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors