Clinical Trials Directory

Trials / Completed

CompletedNCT00648765

Fed Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin® Capsules 1 mg

Single-Dose Food In Vivo Bioequivalence Study of Anagrelide Hydrochloride Capsules (1 mg; Mylan) to Agrylin® Capsules (1 mg; Shire US) in Healthy Volunteers

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Mylan Pharmaceuticals Inc · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1 mg capsules to Shire US's Agrylin® 1 mg capsules following a single, oral 1 mg (1 x 1 mg) dose administration under fed conditions.

Conditions

Interventions

TypeNameDescription
DRUGAnagrelide Hydrochloride Capsules 1 mg1mg, single dose fed
DRUGAgrylin® Capsules 1 mg1mg, single dose fed

Timeline

Start date
2003-01-01
Primary completion
2003-01-01
Completion
2003-01-01
First posted
2008-04-01
Last updated
2024-04-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00648765. Inclusion in this directory is not an endorsement.