HealthyPhase 1NCT00650520

Fed Study of (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets

A Phase 1 study testing BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg and Parlodel® (bromocriptine mesylate) capsules, USP 5 mg in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg bromocriptine mesylate tablets, following the administration of a 10 mg dose, under fed conditions. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg and Parlodel® (bromocriptine mesylate) capsules, USP 5 mg
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 1 siteCanada
Study dates: May 2007to Jul 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 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male or female volunteers, 18-45 years of age.
Subjects will be continuous non-smokers for at least 3 months prior to the first dose or consistent moderate smokers (fewer than 10 cigarettes per day) for at least 3 months prior to the first dosing.
Weighing at least 60 kg for males and 52 kg for females and within the normal range, according to accepted normal values of the Body Mass Index chart (BMI) (18.00-28.00 kg/m2).
Medically healthy subjects with clinically normal laboratory profiles and 12-lead ECG.
Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum;

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IUD (excluding hormone-releasing-IUD) in place for at least 3 months and throughout the study;
barrier methods (condom or diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study;
surgical sterilization of the partner (vasectomy for 6 months minimum). In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 3 days following the last dose.
Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible.
Males must use a spermicide-containing barrier method of contraception to prevent the pregnancy of their female sexual partner from screening, throughout the entire study and for at least 3 days following the last dose.
Give voluntary written informed consent to participate 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, history or presence of:
depression;
seizure or history of EEG abnormalities;
glaucoma or hypermetropia;
frequent migraine episodes;

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alcoholism or drug abuse within the past year;
past psychotic or maniac episodes;
asthma, chronic bronchitis or any other bronchospastic conditions;
peptic ulcer;
hypersensitivity or idiosyncratic reaction to bromocriptine or to any ergot alkaloids related compound;
hypersensitivity or idiosyncratic reaction to, acetaminophen, diphenhydramine, metoclopramide, diazepam or any phenothiazines related compound.
Subjects who tested positive at screening for HIV, HbsAg or HCV.
Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or less than 100/55 mmHg prior to dosing in each period.
Subjects whose sitting blood pressure is more than 140/90 mmHg at screening or prior to dosing in each period.
Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing in each period.
Female subjects who are pregnant or lactating.
Female subjects who are taking hormonal contraceptives or are on hormonal replacement therapy (this includes all formulation, e.g. oral, transdermal, vaginal) during the 28 days prior to the first dose and throughout the study.
Subjects who have used Depo-Provera® or levonorgestrel implant within 90 days prior to the first dose and throughout the study.
Subjects who have received any substance with monoamine oxidase inhibitor (MAOI) activity within 28 days prior to the first dose.
Subjects who have food allergy, problems of galactose intolerance or glucose-galactose malabsorption, or any restriction that, in the opinion of the Principal Investigator, could contraindicate the subject's participation in the study.
Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to the first dose.
Subjects who, through completion of the study, would have donated in excess of:
500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
Subjects who have participated in another clinical trial within 28 days prior to the first dose.

Trial locations and contacts

1 site in 1 country.

Canada1 site

MDS Pharma Services
Montreal, Quebec, H4R 2N6

Other trials in Canada

About this study

Official title: Study of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets Following a 10 mg Dose in Healthy Adult Volunteers Under Fed Conditions

Conditions: Healthy
Being tested: BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg, Parlodel® (bromocriptine mesylate) capsules, USP 5 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mgDrug
4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection
Parlodel® (bromocriptine mesylate) capsules, USP 5 mgDrug
4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection

Study groups in NCT00650520
Study group	Role	What they receive
1	Experimental	Metoclopramide Hydrochloride Injection Sandoz Standard 5mg/mL (10mg/2mL)and BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg Receives: Drug: BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg
2	Active comparator	Metoclopramide Hydrochloride Injection Sandoz Standard 5mg/mL (10mg/2mL) and Parlodel® (bromocriptine mesylate) capsules, USP 5 mg Receives: Drug: Parlodel® (bromocriptine mesylate) capsules, USP 5 mg

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.

May 2007Jul 2007

First posted1 Apr 2008 (estimated)
Study startMay 2007
Primary completionJul 2007
Study completionJul 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: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00650520
Sponsor's protocol ID: BROM-0734
Status last verified: Apr 2024
First submitted: 30 Mar 2008
Last updated: 24 Apr 2024
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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: Study of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets Following a 10 mg Dose in Healthy Adult Volunteers Under Fed Conditions
ClinicalTrials.gov ID: NCT00650520
Acronym / sponsor ID: BROM-0734
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Jul 2007 (actual)
Study completion: Jul 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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mgMetoclopramide Hydrochloride Injection Sandoz Standard 5mg/mL (10mg/2mL)and BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg
2	Active comparator	Drug: Parlodel® (bromocriptine mesylate) capsules, USP 5 mgMetoclopramide Hydrochloride Injection Sandoz Standard 5mg/mL (10mg/2mL) and Parlodel® (bromocriptine mesylate) capsules, USP 5 mg

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Healthy adult male or female volunteers, 18-45 years of age.
Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible.
Males must use a spermicide-containing barrier method of contraception to prevent the pregnancy of their female sexual partner from screening, throughout the entire study and for at least 3 days following the last dose.
Give voluntary written informed consent to participate in the study.

Key exclusion criteria (26 listed)

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of 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
BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection	Drug	1
Parlodel® (bromocriptine mesylate) capsules, USP 5 mg4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection	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.

Gaetano Morelli, M.D. principal investigator

MDS Pharma Services

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 26 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 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?

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?

On the ClinicalTrials.gov record for NCT00650520.

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.