To Determine Bioequivalence Under Fed ConditionsPhase 1NCT00652873
Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions
A Phase 1 study testing Cabergoline and Dostinex in people with To Determine Bioequivalence Under Fed Conditions, run by Par Pharmaceutical, Inc. at 1 site in Canada.
Trial summary
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Determine Bioequivalence Under Fed Conditions
- What is being tested?
- Cabergoline and Dostinex
- 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 siteCanada
- Study dates
- Jul 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
- Subjects will be females or males, smokers or non-smokers
- 18 years of age and older
- Subjects should read, sign and date an Informed Consent Form prior to any study procedures
- Subjects must complete all screening procedures within 28 days prior to the administration of the study medication
Who cannot join
- Breast feeding female subjects
- Clinically significant anormalities found during medical screening
- Any clinically significant gastrointestinal pathology or unresolved gastrointestinal symptoms susceptible of interfering with the absorption of drugs
- Clinically significant illnesses within 4 weeks of the administration of study medication
- Abnormal laboratory tests judged clinically significant
- ECG abnormalities or vital sign abnormalities at screening
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- Subjects with BMI greater than or equal to 30.0
- History of allergic reactions to cabergoline or ergot derivatives
- Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical subinvestigator, contraindicates the subject's participation in the study
- Positive urine drug screen at screening
- Positive testing for hepatitis B, hepatitis C or HIV at screening
- Positive urine pregnancy test at screening (performed on all females)
- Use of investigational drug or participation in an investigational study, within 30 days prior to administration of the study medication
- Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (450 mL) within 56 days prior to the administration of the study medication
- History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day
- History of drug abuse or use of illegal drugs: use of soft drugs (marijuana, pot) within 3 months of the screening visit or hard drugs (cocaine, PCP, crack)within 1 year of the screening visit
- Subjects who have taken prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption
- Female subjects of childbearing potential who have had unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at last 6 months) within 14 days prior to the study drug administration. The acceptable methods of contraception are condom + spermicide (at least 14 days prior to study drug administration), diaphragm + spermicide (at least 14 days prior to study drug administration)or intrauterine contraceptive device (placed at least 4 weeks prior to study drug administration
- Subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication
- Subjects who have undergone clinically significant surgery within 4 weeks prior to the administration of the study medication
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Cabergoline 0.5 mg Tablets and Dostinex 0.5 mg Tablets Administered as 2 x 0.5 mg Tablets in Healthy Adult Females and Males Under Fed Conditions
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
Read the detailed description
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference) administered as 2 x 0.5 mg tablets under fed conditions.
- Being tested
- Cabergoline, Dostinex
- Keywords
- Bioequivalence, Cabergoline, 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.
CabergolineDrug
Also called Dostinex
Tablets 0.5 mg (2 x 0.5 mg dose), fed
DostinexDrug
Also called Cabergoline
Tablets, 0.5 mg (2 X 0.5 mg dose), fed
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received the test product, Cabergoline 0.5 mg tablets under fed conditions Receives: Drug: Cabergoline |
| B | Active comparator | Subjects received the reference product, Dostinex under fed conditions Receives: Drug: Dostinex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and extent of absorption
Measured: 240 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 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 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anapharm
- Investigators
- Eric Masson, Pharm.D., Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652873
- Sponsor's protocol ID
- 01211
- 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
- Randomized, 2-Way Crossover, Bioequivalence Study of Cabergoline 0.5 mg Tablets and Dostinex 0.5 mg Tablets Administered as 2 x 0.5 mg Tablets in Healthy Adult Females and Males Under Fed Conditions
- ClinicalTrials.gov ID
- NCT00652873
- Acronym / sponsor ID
- 01211
- Keywords
- Bioequivalence, Cabergoline, Fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Anapharm
- Study start
- Jul 2001
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (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 rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
Detailed description
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference) administered as 2 x 0.5 mg tablets under fed conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: CabergolineSubjects received the test product, Cabergoline 0.5 mg tablets under fed conditions |
| B | Active comparator | Drug: DostinexSubjects received the reference product, Dostinex under fed conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects will be females or males, smokers or non-smokers
- 18 years of age and older
- Subjects should read, sign and date an Informed Consent Form prior to any study procedures
- Subjects must complete all screening procedures within 28 days prior to the administration of the study medication
Key exclusion criteria (21 listed)
- Breast feeding female subjects
- Clinically significant anormalities found during medical screening
- Any clinically significant gastrointestinal pathology or unresolved gastrointestinal symptoms susceptible of interfering with the absorption of drugs
- Clinically significant illnesses within 4 weeks of the administration of study medication
- Abnormal laboratory tests judged clinically significant
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 |
|---|---|---|
| CabergolineAlso: DostinexTablets 0.5 mg (2 x 0.5 mg dose), fed | Drug | A |
| DostinexAlso: CabergolineTablets, 0.5 mg (2 X 0.5 mg dose), fed | Drug | B |
Primary outcome
Rate and extent of absorption
Time frame: 240 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.
Eric Masson, Pharm.D. principal investigator
Anapharm
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 Cabergoline and Dostinex 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 21 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: 240 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.