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The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma Branded Products Inc.. Following an overnight fast of at least 10 hours, subjects consumed a standard high-calorie, high-fat breakfast meal that began 30 minutes prior to each dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Treatment A (test product) followed by Treatment B (reference product) |
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| 2 | Other | Treatment B (reference product) followed by Treatment A (test product) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| morphine sulfate extended-release capsules | Drug | 2 x 10 mg, single-dose capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Morphine Concentration | 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Maximum Plasma Morphine Concentration | 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs | |
| Area Under the Curve to the Last Measurable Time Point for Plasma Morphine | 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James P. Doherty, DO | CEDRA Clinical Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEDRA Clinical Research, LLC | San Antonio | Texas | 78217 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1: Treatment Aor B | Treatment A (test product) followed by Treatment B (reference product) |
| FG001 | Period 2: Treatment A or B | Treatment B (reference product) followed by Treatment A (test product) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Period 1: Treatment Aor B | Treatment A (test product) followed by Treatment B (reference product) |
| BG001 | Period 2: Treatment A or B | Treatment B (reference product) followed by Treatment A (test product) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximum Plasma Morphine Concentration | Posted | Mean | Standard Deviation | ng/mL | 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs |
|
|
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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 | Arm 1: Treatment A Followed by Treatment B |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meena Venugopal, Director, Clinical R&D | Actavis Inc. | 908-659-2885 | MVenugopal@actavis.com |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| KADIAN (morphine sulfate extended-release) capsules | Drug | 1 x 20 mg, single-dose capsule |
|
|
| Area Under the Curve to Infinity for Plasma Morphine | 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrs |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time of Maximum Plasma Morphine Concentration | Posted | Median | Full Range | Hr | 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs |
|
|
|
| Secondary | Area Under the Curve to the Last Measurable Time Point for Plasma Morphine | Posted | Mean | Standard Deviation | hr*ng/mL | 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs |
|
|
|
|
| Secondary | Area Under the Curve to Infinity for Plasma Morphine | Posted | Mean | Standard Deviation | hr*ng/mL | 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrs |
|
|
|
|
| 0 |
| 0 |
| 4 |
| EG001 | Arm 2: Treatment B Followed by Treatment A | 0 | 0 | 6 |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain in Arm | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Perirectal Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Paratracheal Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |