- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03504475
Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers
December 16, 2018 updated by: Beijing Tongren Hospital
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Beijing Tongren Hospital
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Beijing
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Beijing, Beijing, China, 100730
- Beijing Tongren Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Exclusion Criteria:
- 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.
- Have special diet, cannot control diet and exercise as requested.
- Other situations that the researchers considered unsuitable to enroll the subject.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.
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Active Comparator: Paxil®
During the study session, healthy subjects will be administered a single dose of Paxil® 20mg under Fasting and Fed conditions.
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Paxil® Tablet 20 mg will be used as a comparator drug for the bioequivalence study, manufactured by GlaxoSmithKline(Distributed by: Apotex Corp.).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: Blood samples collected over 96 hour period
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Maximum Observed Concentration (of Paroxetine in Plasma)
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Blood samples collected over 96 hour period
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AUC(0-∞)
Time Frame: Blood samples collected over 96 hour period
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Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
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Blood samples collected over 96 hour period
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AUC(0-t)
Time Frame: Blood samples collected over 96 hour period
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Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
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Blood samples collected over 96 hour period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Xiuli Zhao, PhD, Beijing Tongren Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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