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

NCT00650520 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-04-24

No results posted yet for this study

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

Interventions

DRUG

BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg

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

DRUG

Parlodel® (bromocriptine mesylate) capsules, USP 5 mg

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

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Gaetano Morelli, M.D. · MDS Pharma Services

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00650520 on ClinicalTrials.gov