Clinical trialNCT01948024CompletedPhase 1Interventional

Bio-equivalence Study Between SAPHRIS and Asenapine

SponsorSun Pharmaceutical Industries LimitedEnrollment65Bipolar DisorderSchizophrenia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

David Walling, MD
Collaborative Neuroscience Network, LLC
Principal Investigator
clinicaltrials.gov ↗
Evagelos Coskinas, MD
Clinical Innovations
Principal Investigator
clinicaltrials.gov ↗
Gilbert R. Weiner, DO
Advanced Pharma CR, LLC
Principal Investigator
clinicaltrials.gov ↗
James S. McDonough, MD
Compass Research North, LLC
Principal Investigator
clinicaltrials.gov ↗
Jim G. Aukstuolis, MD
Woodland International Research Group, Inc.
Principal Investigator
clinicaltrials.gov ↗
Kurian Abraham, MD
New Hope Clinical Research, Inc.
Principal Investigator
clinicaltrials.gov ↗
Robert A Riesenberg, MD
Atlanta Center for Medical Research
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Woodland International Research Group, Inc.
Little Rock, Arkansas, United States
Clinical Innovations, Inc
Costa Mesa, California, United States
Collaborative Neuroscience Network, Llc
Garden Grove, California, United States
Compass Research North, Llc
Leesburg, Florida, United States
Advanced Pharma Cr, Llc
Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
New Hope Clinical Research
Charlotte, North Carolina, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Asenapine →SAPHRIS

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jul 2013
Primary completion: 31 Aug 2013
Completion: 31 Aug 2013
Last update posted: 30 Apr 2021
Registered enrollment: 65
Registry id: NCT01948024

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.