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The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vyvanse (LDX) | Experimental |
| |
| Adderall XR (AXR) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate | Drug | 50mg capsule |
| |
| Adderall XR (mixed salts amphetamine) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | 0 through 96 hours after dosing |
| Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | 0 through 96 hours after dosing |
| Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | 0 through 96 hours after dosing |
| Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | 0 through 96 hours after dosing |
| Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | 0 through 96 hours after dosing |
| Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC. | Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, Inc. | Miami | Florida | 33014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19820270 | Result | Haffey MB, Buckwalter M, Zhang P, Homolka R, Martin P, Lasseter KC, Ermer JC. Effects of omeprazole on the pharmacokinetic profiles of lisdexamfetamine dimesylate and extended-release mixed amphetamine salts in adults. Postgrad Med. 2009 Sep;121(5):11-9. doi: 10.3810/pgm.2009.09.2048. | |
| 21474905 | Derived | Wigal T, Brams M, Gasior M, Gao J, Giblin J. Effect size of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. Postgrad Med. 2011 Mar;123(2):169-76. doi: 10.3810/pgm.2011.03.2275. |
| Label | URL |
|---|---|
| FDA recall information | View source |
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Open-label, randomized, four period crossover
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| ID | Title | Description |
|---|---|---|
| FG000 | Vyvanse First | Vyvanse 50mg dosed once in the first intervention, Adderall XR 20 mg dosed once in the second intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the third intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the fourth intervention. |
| FG001 | Adderall XR First | Adderall XR 20 mg dosed once in the first intervention, Vyvanse 50mg dosed once in the second intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the third intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the fourth intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
| |||||||||||||
| Third Intervention |
| |||||||||||||
| Fourth Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| 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 Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | Pharmacokinetic (PK) population defined as all subjects who have evaluable concentration-time profiles. | Posted | Mean | Standard Deviation | ng/ml | 0 through 96 hours after dosing |
|
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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 | Vyvanse |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| C449521 | SLI381 |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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| Drug |
20mg capsule |
|
l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
| 0 through 96 hours after dosing |
| AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | 0 through 96 hours after dosing |
| T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | 0 through 96 hours after dosing |
| Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | Total amphetamine is the d- and l-amphetamines. | 0 through 96 hours after dosing |
| Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | Total amphetamine is the d- and l-amphetamines. | 0 through 96 hours after dosing |
| AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | Total amphetamine is the d- and l-amphetamines. | 0 through 96 hours after dosing |
| T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | Total amphetamine is the d- and l-amphetamines. | 0 through 96 hours after dosing |
| Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing |
| DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC | Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing |
| DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC | Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing |
| Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing |
| Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing |
| Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing |
| Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. | Pre-dose, 2 and 8 hours after dosing |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG003 | Adderall XR + Prilosec OTC |
|
|
| Secondary | Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC. | Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs. | Pharmacodynamic (PD) population defined as all subjects who have evaluable DRQ-S values reported. | Posted | Mean | Standard Deviation | units on a scale | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing |
|
|
|
| Secondary | DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC | Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs. | PD population | Posted | Mean | Standard Deviation | units on a scale | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing |
|
|
|
| Secondary | DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC | Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs. | PD population | Posted | Mean | Standard Deviation | units on a scale | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing |
|
|
|
| Secondary | Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | Safety population defined as subjects who take at least one dose of investigational medicinal product and have at least one post-dose safety assessment. | Posted | Mean | Standard Deviation | mmHg | Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing |
|
|
|
| Primary | Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | PK population | Posted | Mean | Standard Deviation | h | 0 through 96 hours after dosing |
|
|
|
| Primary | Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | PK population | Posted | Mean | Standard Deviation | ng.h/ml | 0 through 96 hours after dosing |
|
|
|
| Primary | Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | PK population | Posted | Mean | Standard Deviation | h | 0 through 96 hours after dosing |
|
|
|
| Secondary | Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | Safety population | Posted | Mean | Standard Deviation | mmHg | Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing |
|
|
|
| Secondary | Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | Safety population | Posted | Mean | Standard Deviation | bpm | Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing |
|
|
|
| Secondary | Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC | QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. | Safety population | Posted | Mean | Standard Deviation | msec | Pre-dose, 2 and 8 hours after dosing |
|
|
|
| Primary | Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | PK population | Posted | Mean | Standard Deviation | ng/ml | 0 through 96 hours after dosing |
|
|
|
| Primary | Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | PK population | Posted | Mean | Standard Deviation | h | 0 through 96 hours after dosing |
|
|
|
| Primary | AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | PK population | Posted | Mean | Standard Deviation | ng.h/ml | 0 through 96 hours after dosing |
|
|
|
| Primary | T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity. | PK population | Posted | Mean | Standard Deviation | h | 0 through 96 hours after dosing |
|
|
|
| Primary | Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | Total amphetamine is the d- and l-amphetamines. | PK population | Posted | Mean | Standard Deviation | ng/ml | 0 through 96 hours after dosing |
|
|
|
| Primary | Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | Total amphetamine is the d- and l-amphetamines. | PK population | Posted | Mean | Standard Deviation | h | 0 through 96 hours after dosing |
|
|
|
| Primary | AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | Total amphetamine is the d- and l-amphetamines. | PK population | Posted | Mean | Standard Deviation | ng.h/ml | 0 through 96 hours after dosing |
|
|
|
| Primary | T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC | Total amphetamine is the d- and l-amphetamines. | PK population | Posted | Mean | Standard Deviation | h | 0 through 96 hours after dosing |
|
|
|
| 0 |
| 24 |
| 8 |
| 24 |
| EG001 | Adderall XR | 0 | 23 | 3 | 23 |
| EG002 | Vyvanse + Prilosec OTC | 0 | 21 | 10 | 21 |
| EG003 | Adderall XR + Prilosec OTC | 0 | 21 | 3 | 21 |
| Tachycardia | Cardiac disorders |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Anxiety | Psychiatric disorders |
|
| Vasospasm | Vascular disorders |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D005021 |
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