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

NCT00650520 | Completed Phase 1

• 1 other identifier: BROM-0734
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  within 30 days

Study Arms (2)

1

EXPERIMENTAL

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

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

Drug: Parlodel® (bromocriptine mesylate) capsules, USP 5 mg

Interventions

BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg DRUG

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

1

Parlodel® (bromocriptine mesylate) capsules, USP 5 mg DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

MDS Pharma Services

Montreal, Quebec, H4R 2N6, Canada

Location

Related Links

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

MeSH Terms

Interventions

Bromocriptine; Capsules

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Gaetano Morelli, M.D.

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 1, 2008
• Study Start: May 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

CA (1)