HealthyPhase 1NCT00840398
Buspirone Hydrochloride 30mg Tablets, Non-Fasting
A Phase 1 study testing BUSPAR® 30 mg Tablet and Buspirone Hydrochloride 30 mg Tablet in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
This study will compare the relative bioavailability (rate and extent of absorption) of 30 mg Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 30 mg BUSPAR® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 30 mg tablet) in healthy adult volunteers under… 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?
- BUSPAR® 30 mg Tablet and Buspirone Hydrochloride 30 mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Dec 2001
- 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
- Screening Demographics: All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The volunteer's body mass index (BMI) is less than or equal to 30.
- Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems.
- The screening clinical laboratory procedures will include:
- Hematology: hematocrit, hemoglobin, RBC count, WBC count with differential, platelet count;
- Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase.
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- HIV antibody and hepatitis B surface antigen screens;
- Urinalysis: by dipstick; full microscopic examination if dipstick positive; and
- Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates, and phencyclidine;
- Serum Pregnancy Screen (female volunteers only).
- If female and:
- of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or
- is postmenopausal for at least 1 year; or
- is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Who cannot join
- Volunteers with a recent history of drug or alcohol addiction or abuse.
- Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
- Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
- Volunteers demonstrating a positive drug abuse screen when screened for this study.
- Female volunteers demonstrating a positive pregnancy screen.
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- Female volunteers who are currently breastfeeding.
- Volunteers with a history of allergic response(s) to buspirone or related drugs.
- Volunteers with a history of clinically significant allergies including drug allergies.
- Volunteers with a clinically significant illness during 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- Volunteers who are currently using or report using tobacco products within 90 days prior to Period I dosing.
- Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.
- Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
- Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
- Volunteers who report taking any prescription medication or nonprescription medication in the 14 days or 7 days, respectively, prior to Period I dosing with the exception of topical products without systemic absorption.
- Volunteers who have been on an abnormal diet during the 28 days prior to Period I dosing.
- Volunteers who report an intolerance or direct venipuncture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Relative Bioavailability Study of 30 mg Buspirone Hydrochloride Tablets Under Non-Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 30 mg Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 30 mg BUSPAR® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 30 mg tablet) in healthy adult volunteers under non-fasting conditions.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- BUSPAR® 30 mg Tablet, Buspirone Hydrochloride 30 mg Tablet
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUSPAR® 30 mg TabletDrug
1 x 30 mg, single-dose fed
Buspirone Hydrochloride 30 mg TabletDrug
1 x 30 mg, single-dose fed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Buspirone Hydrochloride 30 mg Tablet |
| 2 | Active comparator | Not described Receives: Drug: BUSPAR® 30 mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax
Measured: Blood samples collected over 24 hour period
Bioequivalence based on AUC0-inf
Measured: Blood samples collected over 24 hour period
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 24 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startDec 2001
- Primary completionDec 2001
- Study completionDec 2001
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James D. Carlson, Pharm.D., Principal investigator, PRACS Institute, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840398
- Sponsor's protocol ID
- R01-655
- Status last verified
- Aug 2024
- First submitted
- 6 Feb 2009
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of 30 mg Buspirone Hydrochloride Tablets Under Non-Fasting Conditions
- ClinicalTrials.gov ID
- NCT00840398
- Acronym / sponsor ID
- R01-655
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 10 Feb 2009 (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.
This study will compare the relative bioavailability (rate and extent of absorption) of 30 mg Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 30 mg BUSPAR® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 30 mg tablet) in healthy adult volunteers under non-fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Buspirone Hydrochloride 30 mg Tablet |
| 2 | Active comparator | Drug: BUSPAR® 30 mg Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Screening Demographics: All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The volunteer's body mass index (BMI) is less than or equal to 30.
- Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems.
- The screening clinical laboratory procedures will include:
- If female and:
Key exclusion criteria (18 listed)
- Volunteers with a recent history of drug or alcohol addiction or abuse.
- Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
- Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
- Volunteers demonstrating a positive drug abuse screen when screened for this study.
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 |
|---|---|---|
| BUSPAR® 30 mg Tablet1 x 30 mg, single-dose fed | Drug | 2 |
| Buspirone Hydrochloride 30 mg Tablet1 x 30 mg, single-dose fed | Drug | 1 |
Primary outcome
Bioequivalence based on Cmax
Time frame: Blood samples collected over 24 hour period
Bioequivalence based on AUC0-inf
Time frame: Blood samples collected over 24 hour period
Bioequivalence based on AUC0-t
Time frame: Blood samples collected over 24 hour period
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 Aug 2024.
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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.
James D. Carlson, Pharm.D. principal investigator
PRACS Institute, Ltd.
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 BUSPAR® 30 mg Tablet and Buspirone Hydrochloride 30 mg Tablet in people with Healthy, run by Teva Pharmaceuticals USA 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 14 inclusion and 18 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 Aug 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 based on Cmax (time frame: Blood samples collected over 24 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 Aug 2024.