NCT00648778

Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Loxapine Succinate Capsules (25 mg; Mylan) and Loxitane® Capsules (25 mg; Watson) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (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 loxapine succinate 25 mg capsules to Watson Loxitane 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administration under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Loxapine Succinate Capsules 25 mg	25mg, single dose fasting
DRUG	Loxitane® Capsules 25 mg	25mg, single dose fasting

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-02-01
• Completion: 2003-02-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States