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The primary objectives of this study are:
The secondary objective is:
• To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI
The planned duration for this trial is approximately 1.5 to 3 months. The trial includes a 14-day screening period, 3 treatment periods (2 days each), and a follow up visit 7 days after end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence ABC | Experimental |
| |
| Sequence BCA | Experimental |
| |
| Sequence CAB | Experimental |
| |
| Sequence ACB | Experimental |
| |
| Sequence BAC | Experimental |
| |
| Sequence CBA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEV-56248 | Drug | Pharmaceutical form: Dry powder Route of administration: Oral inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp) | Up to 24 hours postdose | |
| Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS) | Up to 24 hours postdose | |
| Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp | Up to 24 hours postdose | |
| Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS | Up to 24 hours postdose | |
| Area Under the Plasma Drug Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Fluticasone Propionate | Up to 24 hours postdose | |
| AUC0-24 of Albuterol Sulfate | Up to 24 hours postdose | |
| Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp | Up to 24 hours postdose | |
| Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS | Up to 24 hours postdose | |
| Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp | Up to 24 hours postdose | |
| Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to 2 Months | |
| Number of Participants with Serious Adverse Events (SAEs) | Up to 2 Months | |
| Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs) |
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Inclusion Criteria:
NOTE- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
NOTE- Additional criteria apply, please contact the investigator for more information
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 12010 | Mobile | Alabama | 36608 | United States | ||
| Teva Investigational Site 12003 |
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
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|
| Fp MDPI | Drug | Pharmaceutical form: Dry powder Route of administration: Oral inhalation |
|
|
| Up to 24 hours postdose |
| Last Measurable Concentration Above the Quantification Limit (Clast) of Fp | Up to 24 hours postdose |
| Last Measurable Concentration Above the Quantification Limit (Clast) of ABS | Up to 24 hours postdose |
| Time of Last Measurable Concentration (tlast) of Fp | Up to 24 hours postdose |
| Time of Last Measurable Concentration (tlast) of ABS | Up to 24 hours postdose |
| Up to 2 Months |
| Long Beach |
| California |
| 90815 |
| United States |
| Teva Investigational Site 12007 | Miami | Florida | 33130 | United States |
| Teva Investigational Site 12005 | Miami | Florida | 33142 | United States |
| Teva Investigational Site 12002 | Miami | Florida | 33155 | United States |
| Teva Investigational Site 12008 | Lafayette | Louisiana | 70508 | United States |
| Teva Investigational Site 12011 | Columbia | Missouri | 65203 | United States |
| Teva Investigational Site 12012 | Oklahoma City | Oklahoma | 73120-9389 | United States |
| Teva Investigational Site 12001 | Boerne | Texas | 78006 | United States |
| Teva Investigational Site 12009 | San Antonio | Texas | 78249 | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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