Bio-equivalence Study Between SAPHRIS and Asenapine
Public ClinicalTrials.gov record NCT01948024. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Randomized, Two Treatment, Multi-site, Multiple Dose, Steady State, Three-way, Reference-replicated Crossover, Pharmacokinetic Study to Determine the In-vivo Bioequivalence Between Asenapine 10 mg Sublingual Tablet and SAPHRIS® (Asenapine) 10 mg Sublingual Tablet
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01948024
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2013
- Primary completion
- Jul 31, 2013
- Completion
- Jul 31, 2013
- Last update posted
- Apr 29, 2021
2013
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland International Research Group, Inc. | Little Rock | Arkansas | 72211 | — |
| Clinical Innovations, Inc | Costa Mesa | California | 92280 | — |
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845 | — |
| Compass Research North, LLC | Leesburg | Florida | 34748 | — |
| Advanced Pharma CR, LLC | Miami | Florida | 33136 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | — |
| New Hope Clinical Research | Charlotte | North Carolina | 28204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01948024, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01948024 live on ClinicalTrials.gov.