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| Name | Class |
|---|---|
| MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan | INDUSTRY |
| Q-Pharm Pty Limited | INDUSTRY |
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The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence: A, B, D, C | Experimental | Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5 |
|
| Treatment sequence: B, C, A, D | Experimental | Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5 |
|
| Treatment sequence: C, D, B, A | Experimental | Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide Inhalation Suspension | Drug | Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010 | The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml). | 8 hours |
| Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min). | 8 hours |
| AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010 | The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg*min/ml). | 8 hours |
| AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml). | 8 hours |
| Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min). | 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Marjason, MBBS | Q-Pharm Pty Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm Pty Limited | Brisbane | Queensland | QLD 4006 | Australia |
All subjects received all 4 treatments in a randomly assigned order. The treatments were:
Treatment A: Pulmicort Respules® Treatment B: MAP0010 low dose Treatment C: MAP0010 intermediate dose Treatment D: MAP0010 high dose The sequences were Treatments ABDC, BACD, CDBA, DACB.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A, B, D, C | Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5 |
| FG001 | Treatment B, C, A, D | Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5 |
| FG002 | Treatment C, D, B, A | Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 5 |
| FG003 | Treatment D, A, C, B | Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All patients that were enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010 | The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml). | Patients with available data at specified time points are included in the analysis population. | Posted | Mean | Standard Deviation | pg/mL | 8 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | a single dose of Pulmicort Respules® delivered by nebulization as per protocol |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thrombophlebitis | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Scientific Affairs | MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan | (650) 386-3100 | dkellerman@mappharma.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Treatment sequence: D, A, C, B | Experimental | Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5 |
|
|
| MAP0010 low dose | Drug | Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. |
|
| MAP0010 intermediate dose | Drug | Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. |
|
| MAP0010 high dose | Drug | Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Treatment C | a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol |
| OG003 | Treatment D | a single dose of MAP0010 high dose delivered by nebulization as per protocol |
|
|
| Primary | Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min). | Patients with available data at specified time points are included in the analysis population. | Posted | Mean | Standard Deviation | min | 8 hours |
|
|
|
| Primary | AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010 | The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg*min/ml). | Patients with available data at specified time points are included in the analysis population. | Posted | Mean | Standard Deviation | pg*min/mL | 8 hours |
|
|
|
| Primary | AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml). | Patients with available data at specified time points are included in the analysis population. | Posted | Mean | Standard Deviation | pg*min/mL | 8 hours |
|
|
|
| Primary | Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min). | Posted | Mean | Standard Deviation | min | 8 hours |
|
|
|
| 0 |
| 16 |
| 4 |
| 16 |
| EG001 | Treatment B | a single dose of MAP0010 low dose delivered by nebulization as per protocol | 0 | 16 | 4 | 16 |
| EG002 | Treatment C | a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol | 0 | 16 | 3 | 16 |
| EG003 | Treatment D | a single dose of MAP0010 high dose delivered by nebulization as per protocol | 0 | 16 | 3 | 16 |
| hematoma | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
|
| epitaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| herpes simplex | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| vaginal candidiasis | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| hordeolum | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
|
| dysmenorrhoea | Reproductive system and breast disorders | MedDRA (8.1) | Systematic Assessment |
|
| eye irritation | Eye disorders | MedDRA (8.1) | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |