To Determine Bioequivalence Under Fed ConditionsPhase 1NCT00652730
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions
A Phase 1 study testing Buspirone HCl and Buspar in people with To Determine Bioequivalence Under Fed Conditions, run by Par Pharmaceutical, Inc. at 1 site in Canada.
Trial summary
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- To Determine Bioequivalence Under Fed Conditions
- What is being tested?
- Buspirone HCl and Buspar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Jul 1998to Sep 1998
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, 18-45 years of age
- Weighing at least 60 kg, who are within 10% of their ideal weights (Table of "Desirable Weights of Adults", metropolitan Life Insurance Company, 1983)
- Physical examination and laboratory tests of hematologic, hepatic and renal functions.
- Medically healthy subjects with clinically normal laboratory profiles will be enrolled in the study
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- In addition, the presence of alcoholism or drug abuse within the past year: hypersensitivity or idiosyncratic reaction to buspirone HCl.
- Subjects who have been receiving monoamine oxidase inhibitors.
- Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
- Subjects who, through completion of the study, would have donated in excess of 500 mL blood in 14 days, or 500-750 mL blood in 14 days (unless approved by the Principal Investigator, 1000 mL blood in 90 days, 1250 mL blood in 120 days, 1500 mL blood in 180 days, 2000 mL blood in 270 days, 2500 mL blood in 1 year.
- Subjects who have participated in another clinical trial with 28 days of study start.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Phoenix International Life Sciences inc
Saint-Laurent, Quebec, H4R 2N6
About this study
Official title: Comparative, Randomized, 3-Way Crossover Bioavailability Study of Par and Bristol-Myers Squibb (Buspar)15 mg Buspirone HCl Tablets Following Administration of a 30 mg Dose in Healthy Adult Males Under Fed and Fasting Conditions
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
Read the detailed description
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg buspirone HCl tablets, following administration of a 30 mg dose, under fed conditions. In addition, the bioavailability of the Par product was compared under fed and fasting conditions.
- Being tested
- Buspirone HCl, Buspar
- Keywords
- bioequivalence, buspirone HCl, fed
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buspirone HClDrug
Also called Buspar
Tablets, 30 mg, single-dose, fasting conditions
Buspirone HClDrug
Also called Buspar
Tablets, 30 mg, single-dose, fed conditions
BusparDrug
Also called Buspirone HCl
Tablets, 30 mg, single-dose, fed conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received the Par formulated product under fasting conditions Receives: Drug: Buspirone HCl |
| B | Experimental | Subjects received the Par formulated product under fed conditions Receives: Drug: Buspirone HCl |
| C | Active comparator | Subjects received the Bristol-Myers Squibb formulated product under fed conditions Receives: Drug: Buspar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and extent of absorption
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startJul 1998
- Primary completionSep 1998
- Study completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine Bioequivalence Under Fed ConditionsStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Phoenix International Life Sciences, Inc.
- Investigators
- Samuel Surfaty, MD, Principal investigator, Phoenix International Life Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652730
- Sponsor's protocol ID
- 980564
- Status last verified
- Sep 2017
- First submitted
- 1 Apr 2008
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, 3-Way Crossover Bioavailability Study of Par and Bristol-Myers Squibb (Buspar)15 mg Buspirone HCl Tablets Following Administration of a 30 mg Dose in Healthy Adult Males Under Fed and Fasting Conditions
- ClinicalTrials.gov ID
- NCT00652730
- Acronym / sponsor ID
- 980564
- Keywords
- bioequivalence, buspirone HCl, fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Phoenix International Life Sciences, Inc.
- Study start
- Jul 1998
- Primary completion
- Sep 1998 (actual)
- Study completion
- Sep 1998 (actual)
- First posted
- 4 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.
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
Detailed description
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg buspirone HCl tablets, following administration of a 30 mg dose, under fed conditions. In addition, the bioavailability of the Par product was compared under fed and fasting conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Buspirone HClSubjects received the Par formulated product under fasting conditions |
| B | Experimental | Drug: Buspirone HClSubjects received the Par formulated product under fed conditions |
| C | Active comparator | Drug: BusparSubjects received the Bristol-Myers Squibb formulated product under fed conditions |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteers, 18-45 years of age
- Weighing at least 60 kg, who are within 10% of their ideal weights (Table of "Desirable Weights of Adults", metropolitan Life Insurance Company, 1983)
- Physical examination and laboratory tests of hematologic, hepatic and renal functions.
- Medically healthy subjects with clinically normal laboratory profiles will be enrolled in the study
Key exclusion criteria (6 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- In addition, the presence of alcoholism or drug abuse within the past year: hypersensitivity or idiosyncratic reaction to buspirone HCl.
- Subjects who have been receiving monoamine oxidase inhibitors.
- Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
- Subjects who, through completion of the study, would have donated in excess of 500 mL blood in 14 days, or 500-750 mL blood in 14 days (unless approved by the Principal Investigator, 1000 mL blood in 90 days, 1250 mL blood in 120 days, 1500 mL blood in 180 days, 2000 mL blood in 270 days, 2500 mL blood in 1 year.
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 |
|---|---|---|
| Buspirone HClAlso: BusparTablets, 30 mg, single-dose, fasting conditions | Drug | A |
| Buspirone HClAlso: BusparTablets, 30 mg, single-dose, fed conditions | Drug | B |
| BusparAlso: Buspirone HClTablets, 30 mg, single-dose, fed conditions | Drug | C |
Primary outcome
Rate and extent of absorption
Time frame: 24 hours
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 26 Sep 2017.
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.
Samuel Surfaty, MD principal investigator
Phoenix International Life Sciences, Inc.
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 Buspirone HCl and Buspar in people with To Determine Bioequivalence Under Fed Conditions, run by Par Pharmaceutical, Inc. at 1 site in Canada.
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 6 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 26 Sep 2017. 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 Canada. 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?
Rate and extent of absorption (time frame: 24 hours). 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 26 Sep 2017.