MedTrace Logo

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

NCT00648778 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2024-04-24

No results posted yet for this study

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

DRUG

Loxapine Succinate Capsules 25 mg

25mg, single dose fasting

DRUG

Loxitane® Capsules 25 mg

25mg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Thomas S Clark, M.D. · Kendle International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2003-02-28
Completion
2003-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT00648778 on ClinicalTrials.gov