NCT00648024

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

Single-Dose Fasting 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: 47 (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 fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Anagrelide Hydrochloride Capsules 1 mg	1mg, single dose fasting
DRUG	Agrylin® Capsules 1 mg	1mg, single dose fasting

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