Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Asenapine 3x followed by 1x · 1 trial · 2 indications
The primary objective is to compare the bioavailability using pharmacokinetic parameter of maximum plasma concentration (Cmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222 Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2.
The primary objective is to compare the bioavailability using pharmacokinetic parameter of time of occurrence of Cmax (Tmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222. Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2
The primary objective is to compare the bioavailability using pharmacokinetic parameter of area under the curve (AUC) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222. Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2.
| Arm | Type | Description |
|---|---|---|
| Asenapine Sequence 1 | EXPERIMENTAL | - |
| Asenapine Sequence 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Asenapine 3x5mg followed by 1x15mg | DRUG | Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days |
| Asenapine 1x15mg followed by 3x5mg | DRUG | One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days. |
Inclusion Criteria: * must provide written informed consent after the scope and nature of the investigation has been explained to them, but before signing any trial-related activities, including screening evaluations; * must be at least 18 and less than 65 years of age; * can be either male or fema...
Asenapine 3x followed by 1x is an investigational small molecule being studied for the treatment of schizophrenia. It is a sublingual formulation of asenapine, and the regimen refers to taking three 5 mg tablets followed by one 15 mg tablet. It is currently in Phase 2 clinical development.
Asenapine 3x followed by 1x is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The drug is an investigational small molecule intended for the treatment of schizophrenia.
Asenapine 3x followed by 1x is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug remains under investigation for schizophrenia.
Asenapine 3x followed by 1x has one completed clinical trial, NCT01101464, which was a Phase 2 study. The trial compared the safety and equivalence of two differing strength tablets, 3 x 5 mg versus 1 x 15 mg, in subjects with schizophrenia or schizoaffective disorder.
Asenapine 3x followed by 1x is a specific dosing regimen of the drug asenapine, administered sublingually. The regimen involves taking three 5 mg tablets followed by one 15 mg tablet. It is being studied to determine if these two dosing approaches are safe and equivalent in patients with schizophrenia.