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

NCT ID: NCT00650520

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2007-07-31

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

Metoclopramide Hydrochloride Injection Sandoz Standard 5mg/mL (10mg/2mL)and BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg

Group Type: EXPERIMENTAL

BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg

Intervention Type: DRUG

4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection

2

Metoclopramide Hydrochloride Injection Sandoz Standard 5mg/mL (10mg/2mL) and Parlodel® (bromocriptine mesylate) capsules, USP 5 mg

Group Type: ACTIVE_COMPARATOR

Parlodel® (bromocriptine mesylate) capsules, USP 5 mg

Intervention Type: DRUG

4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection

Interventions

BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg

4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection

Intervention Type: DRUG

Parlodel® (bromocriptine mesylate) capsules, USP 5 mg

4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum;

2. IUD (excluding hormone-releasing-IUD) in place for at least 3 months and throughout the study;

3. barrier methods (condom or diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study;

4. 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.

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mylan Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Mylan Inc.

Principal Investigators

Gaetano Morelli, M.D.

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Locations

MDS Pharma Services

Montreal, Quebec, Canada

Countries

Canada

Related Links

http://www.mpibiostudies.com

Mylan Pharmaceuticals Inc. - Clinical Trial Results

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use

http://www.fda.gov/opacom/7alerts.html

Recalls, Market Withdrawals and Safety Alerts

Other Identifiers

BROM-0734

Identifier Type: -

Identifier Source: org_study_id