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Bio-equivalence Study Between SAPHRIS and Asenapine

NCT01948024 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-04-30

No results posted yet for this study

Summary

This is a Multiple-dose, steady state, three-way reference-replicated crossover study.

The purpose of this Study is to determine the bio-equivalence between SAPHRIS and Asenapine 10mg sublingual tablets.

Conditions

  • Schizophrenia
  • Bipolar Disorder

Interventions

DRUG

SAPHRIS

10 mg BID sublingual tablet

DRUG

Asenapine

10 mg BID sublingual tablet

Sponsors & Collaborators

  • bioRASI, LLC

    collaborator INDUSTRY

  • Sun Pharmaceutical Industries Limited

    lead INDUSTRY

Principal Investigators

  • David Walling, MD · Collaborative Neuroscience Network, LLC

  • Robert A Riesenberg, MD · Atlanta Center for Medical Research

  • Kurian Abraham, MD · New Hope Clinical Research, Inc.

  • Evagelos Coskinas, MD · Clinical Innovations

  • James S. McDonough, MD · Compass Research North, LLC

  • Gilbert R. Weiner, DO · Advanced Pharma CR, LLC

  • Jim G. Aukstuolis, MD · Woodland International Research Group, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

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 NCT01948024 on ClinicalTrials.gov