HealthyPhase 1NCT00650403
Food Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg
A Phase 1 study testing Paroxetine hydrochloride 40 mg tablet and Paxil® 40 mg Tablet in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
Trial summary
The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions to healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Paroxetine hydrochloride 40 mg tablet and Paxil® 40 mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jan 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing.
- Subjects who completed the screening process within 21 days prior to Period I dosing.
- Subjects who were healthy adult men and women at least 18 years of age at the time of dosing.
- Subjects who weighed at least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women. All subjects must have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 19.
- Subjects who were healthy as documented by the medical history, physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range which was considered clinically relevant by the study physician and investigator was evaluated for individual cases, documented in study files, and agreed upon by the investigator and clinic personnel prior to enrolling a volunteer in this study and for continued enrollment.
- Subjects who had a negative urine drug screen.
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- Female subjects who had a negative pregnancy screen.
- Female subjects were physically incapable of pregnancy - surgically sterile (bilateral oophorectomy with an absence of bleeding for six months, with or without a hysterectomy, or total hysterectomy and an absence of bleeding for at least three months) or post-menopausal with an absence of menses for at least 12 months.
- During the course of the study, from study screen until study exit - including the washout period, all men used a spermicide containing barrier method of contraception.
Who cannot join
- Institutionalized subjects were not used.
- Social Habits: a. Use of any tobacco-containing products within one (1) year prior to dosing. b. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication. c. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. d. Any recent, significant change in dietary or exercise habits. e. A positive test for any drug included in the urine drug screen. f. History of drug and/or alcohol abuse.
- Medications: a. Use of any prescription or over-the-counter (OTC) medication within the 14 days prior to the initial dose of study medication. b. Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing. c. Use of any medication within 28 days prior to initial dose of study medication unless the Pharmacokinetics/Drug Metabolism Department at Mylan was consulted and a decision was made to allow the subjects to enroll based on the medications pharmacology and pharmacokinetics. d. Use of monoamine oxidase inhibitors (MAOIs), pimozide, or thioridazine within 30 days prior to the initial dosing of study medication.
- Diseases: a. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease. b. Acute illness at the time of either the pre-study medical evaluation or dosing. c. A positive HIV, hepatitis B, or hepatitis C test.
- Abnormal and clinically significant laboratory test results: a. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities. b. Abnormal and clinically relevant ECG tracing.
- Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
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- Subjects who received an investigational drug within 30 days prior to the initial dose of study medication.
- Allergy or hypersensitivity to paroxetine or other related products.
- History of difficulties swallowing, or any gastrointestinal disease which could affect the drug absorption.
- Consumption of grapefruit or grapefruit containing products within seven (7) days of drug administration.
- History of depression, mania, seizure, akathisia, narrow angle glaucoma, and/or suicidal ideation or behavior (suicidality).
Trial locations and contacts
1 site in 1 country.
United States1 site
Gateway Medical Research, Inc.
Saint Charles, Missouri, 63301
About this study
Official title: Single-Dose Fed Bioequivalence Study of Paroxetine Hydrochloride Tablets (40 mg; Mylan) and Paxil® Tablets (40 mg; GSK) in Healthy Adult Volunteers
The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions to healthy adult volunteers.
- Conditions
- Healthy
- Being tested
- Paroxetine hydrochloride 40 mg tablet, Paxil® 40 mg Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paroxetine hydrochloride 40 mg tabletDrug
40mg, single dose fed
Paxil® 40 mg TabletDrug
40mg, single dose fed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Paroxetine hydrochloride 40 mg tablet Receives: Drug: Paroxetine hydrochloride 40 mg tablet |
| 2 | Active comparator | Paxil® 40 mg Tablet Receives: Drug: Paxil® 40 mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bruce T Czarnik, M.D., Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650403
- Sponsor's protocol ID
- PARO-0679
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2008
- Last updated
- 24 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Fed Bioequivalence Study of Paroxetine Hydrochloride Tablets (40 mg; Mylan) and Paxil® Tablets (40 mg; GSK) in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00650403
- Acronym / sponsor ID
- PARO-0679
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 1 Apr 2008 (estimated)
- 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 investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions to healthy adult volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Paroxetine hydrochloride 40 mg tabletParoxetine hydrochloride 40 mg tablet |
| 2 | Active comparator | Drug: Paxil® 40 mg TabletPaxil® 40 mg Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing.
- Subjects who completed the screening process within 21 days prior to Period I dosing.
- Subjects who were healthy adult men and women at least 18 years of age at the time of dosing.
- Subjects who weighed at least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women. All subjects must have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 19.
- Subjects who were healthy as documented by the medical history, physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range which was considered clinically relevant by the study physician and investigator was evaluated for individual cases, documented in study files, and agreed upon by the investigator and clinic personnel prior to enrolling a volunteer in this study and for continued enrollment.
Key exclusion criteria (11 listed)
- Institutionalized subjects were not used.
- Social Habits: a. Use of any tobacco-containing products within one (1) year prior to dosing. b. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication. c. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. d. Any recent, significant change in dietary or exercise habits. e. A positive test for any drug included in the urine drug screen. f. History of drug and/or alcohol abuse.
- Medications: a. Use of any prescription or over-the-counter (OTC) medication within the 14 days prior to the initial dose of study medication. b. Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing. c. Use of any medication within 28 days prior to initial dose of study medication unless the Pharmacokinetics/Drug Metabolism Department at Mylan was consulted and a decision was made to allow the subjects to enroll based on the medications pharmacology and pharmacokinetics. d. Use of monoamine oxidase inhibitors (MAOIs), pimozide, or thioridazine within 30 days prior to the initial dosing of study medication.
- Diseases: a. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease. b. Acute illness at the time of either the pre-study medical evaluation or dosing. c. A positive HIV, hepatitis B, or hepatitis C test.
- Abnormal and clinically significant laboratory test results: a. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities. b. Abnormal and clinically relevant ECG tracing.
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 40 mg tablet40mg, single dose fed | Drug | 1 |
| Paxil® 40 mg Tablet40mg, single dose fed | Drug | 2 |
Primary outcome
Bioequivalence
Time frame: within 30 days
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 24 Apr 2024.
- Mylan Pharmaceuticals Inc. - Clinical Trial ResultsLink provided by the sponsor.
- Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in useLink provided by the sponsor.
- Recalls, Market Withdrawals and Safety AlertsLink provided by the sponsor.
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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.
Bruce T Czarnik, M.D. principal investigator
Cetero Research, San Antonio
1 site 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 40 mg tablet and Paxil® 40 mg Tablet in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
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 9 inclusion and 11 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 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Bioequivalence (time frame: within 30 days). 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 24 Apr 2024.