Major Depressive DisorderPhase 1NCT03504475
Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers
A Phase 1 study testing Paroxetine Hydrochloride Tablet 20 mg and Paxil® 20 mg in people with Major Depressive Disorder and Obsessive-Compulsive Disorder, run by Beijing Tongren Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Obsessive-Compulsive Disorder, Panic Disorder
- What is being tested?
- Paroxetine Hydrochloride Tablet 20 mg and Paxil® 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesChina
- Study dates
- 29 Mar 2018to 16 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing TongRen Hospital
Beijing, Beijing Municipality, 100730
Beijing TongRen Hospital
Beijing
About this study
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
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder
- Being tested
- Paroxetine Hydrochloride Tablet 20 mg, Paxil® 20 mg
- Medical subject headings
- Depressive Disorder, Major, Obsessive-Compulsive Disorder, Panic Disorder, Phobia, Social, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paroxetine Hydrochloride Tablet 20 mgDrug
A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.
Paxil® 20 mgDrug
Also called Paroxetine Hydrochloride Tablet 20 mg
Paxil® Tablet 20 mg will be used as a comparator drug for the bioequivalence study, manufactured by GlaxoSmithKline（Distributed by: Apotex Corp.）.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Paxil® 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Observed Concentration (of Paroxetine in Plasma)
Measured: Blood samples collected over 96 hour period
AUC(0-∞)
Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Measured: 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)
Measured: Blood samples collected over 96 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start29 Mar 2018
- Primary completion24 Apr 2018
- Study completion16 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Winsunny Pharmceutical Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Xiuli Zhao, PhD, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504475
- Sponsor's protocol ID
- WS-CP-06-201709-01
- Status last verified
- May 2018
- First submitted
- 12 Apr 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03504475
- Acronym / sponsor ID
- WS-CP-06-201709-01
- Conditions
- Major Depressive Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Beijing Winsunny Pharmceutical Co.,Ltd.
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 16 Jun 2018 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paroxetine Hydrochloride Tablet | Experimental | Drug: Paroxetine Hydrochloride Tablet 20 mgDuring the study session, healthy subjects will be administered a single dose of Paroxetine Hydrochloride Tablet 20mg under Fasting and Fed conditions. |
| Paxil® | Active comparator | Drug: Paxil® 20 mgDuring the study session, healthy subjects will be administered a single dose of Paxil® 20mg under Fasting and Fed conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paroxetine Hydrochloride Tablet 20 mgA generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd. | Drug | Paroxetine Hydrochloride Tablet |
| Paxil® 20 mgAlso: Paroxetine Hydrochloride Tablet 20 mgPaxil® Tablet 20 mg will be used as a comparator drug for the bioequivalence study, manufactured by GlaxoSmithKline（Distributed by: Apotex Corp.）. | Drug | Paxil® |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuli Zhao, PhD principal investigator
Beijing Tongren Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paroxetine Hydrochloride Tablet 20 mg and Paxil® 20 mg in people with Major Depressive Disorder and Obsessive-Compulsive Disorder, run by Beijing Tongren Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Blood samples collected over 96 hour period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.