Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00746733
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 15.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Lisdexamfetamine Dimesylate; Drug: Adderall XR (mixed salts amphetamine)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Phase I, Open-Label, Randomized, Four Period Crossover Drug Interaction Study to Evaluate the Pharmacokinetic Profiles of VYVANSE™ and ADDERALL XR When Each is Administered Alone and in Combination With the Proton Pump Inhibitor Prilosec OTC™ in Healthy Adult Volunteers
• Actual Study Start Date: Sep 8, 2008
• Actual Primary Completion Date: Oct 26, 2008
• Actual Study Completion Date: Oct 26, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vyvanse (LDX)	Drug: Lisdexamfetamine Dimesylate; 50mg capsule
Experimental: Adderall XR (AXR)	Drug: Adderall XR (mixed salts amphetamine); 20mg capsule

Outcome Measures

Primary Outcome Measures

1. Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [0 through 96 hours after dosing]

   d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

2. Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [0 through 96 hours after dosing]

   d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

3. 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 [0 through 96 hours after dosing]

   d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

4. Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [0 through 96 hours after dosing]

   d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

5. Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [0 through 96 hours after dosing]

   l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

6. Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [0 through 96 hours after dosing]

   l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

7. AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [0 through 96 hours after dosing]

8. T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [0 through 96 hours after dosing]

   l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

9. Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [0 through 96 hours after dosing]

   Total amphetamine is the d- and l-amphetamines.

10. Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [0 through 96 hours after dosing]

    Total amphetamine is the d- and l-amphetamines.

11. AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [0 through 96 hours after dosing]

    Total amphetamine is the d- and l-amphetamines.

12. T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [0 through 96 hours after dosing]

    Total amphetamine is the d- and l-amphetamines.

Secondary Outcome Measures

1. Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC. [Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing]

   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.

2. DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC [Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing]

   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.

3. DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC [Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing]

   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.

4. 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]

5. 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]

6. 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]

7. Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [Pre-dose, 2 and 8 hours after dosing]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy volunteers, age 18 to 45 inclusive at the time of consent.

2. Male, or non-pregnant, non-lactating female

3. Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening, and a negative urine pregnancy test on Day -1 after checking into the clinic the day before the first dose of investigational product.

4. Body Mass Index (BMI) between 20.0 and 30.0 kg/m² inclusive. This inclusion criterion will only be assessed at the first screening visit.

5. Satisfactory medical assessment with no significant or relevant abnormality in medical history, physical examination (PE), vital signs and laboratory evaluation

6. Normal or clinically insignificant Screening ECG findings as assessed by the Investigator.

7. Ability to swallow investigational products.

Exclusion Criteria:

1. Current or recurrent disease that could affect the action, absorption or disposition of the investigational products, or could affect clinical or laboratory assessments.

2. Current or relevant previous history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational products or study procedures.

3. Significant illness, as judged by the Investigator, within 2 weeks of the first dose of investigational product.

4. History of significant anxiety, tension or agitation as assessed by the Investigator.

5. History of or current diagnosis of glaucoma.

6. History of a seizure disorder (other than infantile febrile seizures), any tic disorder or a current diagnosis and/or known family history of Tourette's Disorder.

7. History of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

8. History of controlled or uncontrolled hypertension or a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg.

9. Known family history of sudden cardiac death or ventricular arrhythmia.

10. Currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation.

11. Current use of any medication (including prescription, over the counter [OTC], herbal or homeopathic preparations) with the exception of hormonal replacement therapy or hormonal contraceptives (Current use is defined as use within 14 days of first dose of investigational product).

12. Use of any medication known to inhibit or induce the CYP450 enzymes responsible for the metabolism of the investigational products within 14 days of first dose of investigational product.

13. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds or any of the stated ingredients.

14. History of alcohol or other substance abuse within the last year.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami, Inc.	Miami	Florida	United States	33014

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• FDA recall information
• FDA-approved label

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT00746733
• Other Study ID Numbers: SPD489-113
• First Posted: Sep 4, 2008
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by Shire: Drug; Interaction; Study
• Additional relevant MeSH terms: Amphetamine; Lisdexamfetamine Dimesylate; Adderall

Study Results

Participant Flow

Pre-assignment Detail	Open-label, randomized, four period crossover

Arm/Group Title	Vyvanse First	Adderall XR First
Arm/Group Description	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.	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.
Period Title: First Intervention
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	12	12
COMPLETED	11	12
NOT COMPLETED	1	0
Period Title: First Intervention
STARTED	11	12
COMPLETED	10	11
NOT COMPLETED	1	1
Period Title: First Intervention
STARTED	10	11
COMPLETED	10	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description
Overall Participants	24
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	24 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.7 (6.54)
Sex: Female, Male (Count of Participants)
Female	6 25%
Male	18 75%
Region of Enrollment (Count of Participants)
United States	24 100%

Outcome Measures

1. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Description	d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population defined as all subjects who have evaluable concentration-time profiles.

Arm/Group Title	Vyvanse	Adderall XR	Vyvanse + Prilosec OTC	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	24	23	21	21
Mean (Standard Deviation) [ng/ml]	45.04 (13.971)	28.66 (7.174)	46.34 (9.710)	29.97 (5.719)

2. Secondary Outcome

Title	Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
Description	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.
Time Frame	Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing

Outcome Measure Data

Analysis Population Description

Pharmacodynamic (PD) population defined as all subjects who have evaluable DRQ-S values reported.

Arm/Group Title	Vyvanse + Prilosec OTC	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	21	21
Pre-dose	1.0 (0.0)	1.0 (0.0)
0.5 h	1.2 (0.60)	2.0 (3.09)
1 h	1.8 (1.75)	2.0 (3.08)
1.5 h	4.6 (8.28)	2.2 (3.56)
2 h	4.6 (8.33)	2.5 (4.56)
2.5 h	3.9 (6.04)	2.3 (3.73)
3 h	3.5 (5.78)	1.5 (1.03)
3.5 h	2.7 (3.78)	1.3 (0.80)
4 h	1.7 (1.06)	1.4 (0.86)
5 h	2.4 (3.93)	1.3 (0.72)
6 h	1.4 (0.81)	1.2 (0.51)
8 h	1.4 (0.74)	1.3 (1.32)
12 h	1.2 (0.62)	1.1 (0.36)
24 h	1.3 (0.72)	1.0 (0.22)

3. Secondary Outcome

Title	DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
Description	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.
Time Frame	Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing

Outcome Measure Data

Analysis Population Description

PD population

Arm/Group Title	Vyvanse + Prilosec OTC	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	21	21
Pre-dose	1.0 (0.0)	1.0 (0.0)
0.5 h	1.3 (0.73)	1.3 (0.66)
1 h	2.1 (2.66)	1.9 (2.46)
1.5 h	5.2 (8.38)	2.3 (2.97)
2 h	6.0 (8.69)	3.5 (5.33)
2.5 h	6.0 (7.59)	3.5 (4.64)
3 h	5.3 (6.72)	2.7 (3.36)
3.5 h	4.9 (6.09)	2.1 (2.01)
4 h	3.8 (4.57)	2.1 (1.84)
5 h	3.1 (4.13)	1.9 (1.74)
6 h	3.4 (3.60)	1.5 (0.87)
8 h	3.0 (4.26)	1.3 (0.66)
12 h	4.4 (7.19)	1.2 (0.54)
24 h	1.6 (1.40)	1.0 (0.22)

4. Secondary Outcome

Title	DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
Description	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.
Time Frame	Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing

Outcome Measure Data

Analysis Population Description

PD population

Arm/Group Title	Vyvanse + Prilosec OTC	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	21	21
Pre-dose	1.0 (0.0)	1.0 (0.0)
0.5 h	2.0 (3.49)	2.1 (3.11)
1 h	1.8 (1.67)	2.0 (3.08)
1.5 h	4.3 (8.03)	1.8 (1.55)
2 h	4.5 (8.37)	1.4 (0.93)
2.5 h	3.8 (6.39)	1.4 (0.80)
3 h	3.4 (5.78)	1.2 (0.54)
3.5 h	2.6 (3.54)	1.3 (0.72)
4 h	1.8 (1.18)	1.3 (0.80)
5 h	2.3 (4.13)	1.3 (0.97)
6 h	1.6 (1.02)	1.2 (0.70)
8 h	1.6 (1.78)	1.1 (0.48)
12 h	1.3 (0.80)	1.2 (0.51)
24 h	1.1 (0.48)	1.0 (0.22)

5. Secondary Outcome

Title	Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Time Frame	Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing

Outcome Measure Data

Analysis Population Description

Safety population defined as subjects who take at least one dose of investigational medicinal product and have at least one post-dose safety assessment.

Arm/Group Title	Vyvanse	Adderall XR	Vyvanse + Prilosec OTC	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	24	23	21	21
Pre-dose	115.6 (10.79)	115.3 (10.26)	114.8 (11.29)	113.9 (11.71)
1 h	122.8 (11.10)	121.0 (10.46)	121.7 (13.31)	122.6 (9.67)
2 h	127.9 (12.81)	122.2 (11.34)	125.5 (10.14)	124.7 (12.74)
4 h	127.6 (12.95)	120.8 (11.71)	125.2 (11.50)	124.2 (9.75)
8 h	126.0 (12.69)	122.4 (11.04)	123.5 (13.25)	119.2 (10.99)
12 h	123.4 (15.62)	121.9 (12.04)	122.2 (13.19)	118.4 (10.58)
24 h	114.0 (11.68)	118.1 (12.97)	114.7 (11.19)	115.6 (13.42)
48 h	114.6 (12.84)	112.6 (10.56)	114.4 (10.81)	113.6 (11.01)
72 h	113.7 (10.25)	114.8 (11.81)	115.1 (11.71)	116.0 (9.74)
96 h	114.0 (10.53)	114.5 (10.72)	114.8 (11.06)	116.1 (9.29)

6. Primary Outcome

Title	Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Description	d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

PK population

Arm/Group Title	Vyvanse	Adderall XR	Vyvanse + Prilosec OTC	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	24	23	21	21
Mean (Standard Deviation) [h]	3.5 (1.14)	5.2 (3.10)	3.5 (0.97)	3.3 (1.45)

7. Primary Outcome

Title	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
Description	d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

PK population

Arm/Group Title	Vyvanse	Adderall XR	Vyvanse + Prilosec OTC	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	24	23	21	21
Mean (Standard Deviation) [ng.h/ml]	626.27 (198.982)	473.70 (71.043)	687.00 (196.906)	472.35 (108.891)

8. Primary Outcome

Title	Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Description	d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

PK population

Arm/Group Title	Vyvanse	Adderall XR	Vyvanse + Prilosec OTC	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	24	23	21	21
Mean (Standard Deviation) [h]	9.7 (1.55)	10.25 (1.36)	10.4 (1.65)	10.91 (1.95)

9. Secondary Outcome

Title	Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Time Frame	Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Vyvanse	Adderall XR	Vyvanse + Prilosec OTC	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	24	23	21	21
Pre-dose	76.0 (6.68)	74.1 (6.72)	77.7 (8.60)	75.8 (7.80)
1 h	79.2 (6.62)	76.4 (5.98)	80.5 (9.52)	80.4 (6.29)
2 h	79.0 (6.97)	75.4 (6.58)	82.0 (6.44)	81.9 (8.71)
4 h	79.9 (7.91)	77.7 (6.31)	82.0 (7.68)	82.0 (7.09)
8 h	78.6 (7.87)	74.1 (5.73)	80.3 (9.54)	79.2 (7.96)
12 h	79.6 (9.45)	78.5 (8.29)	78.7 (10.47)	77.8 (8.20)
24 h	75.9 (6.76)	76.8 (8.62)	75.0 (7.76)	75.4 (7.30)
48 h	74.5 (8.39)	73.5 (8.40)	77.2 (6.53)	74.4 (8.01)
72 h	75.1 (7.97)	74.7 (7.24)	76.1 (7.58)	77.9 (6.77)
96 h	74.5 (8.02)	75.7 (7.65)	75.7 (7.48)	78.3 (6.96)

10. Secondary Outcome

Title	Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Time Frame	Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Vyvanse	Adderall XR	Vyvanse + Prilosec OTC	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	24	23	21	21
Pre-dose	70.9 (9.87)	69.0 (8.87)	73.3 (10.16)	71.4 (10.14)
1 h	69.7 (10.61)	70.0 (11.29)	73.4 (10.91)	73.8 (13.78)
2 h	78.2 (11.64)	75.2 (10.85)	83.4 (14.68)	80.5 (16.87)
4 h	79.0 (14.40)	74.5 (12.62)	84.4 (16.29)	78.4 (15.03)
8 h	84.8 (11.38)	79.1 (10.70)	87.7 (14.34)	81.5 (11.50)
12 h	86.4 (13.84)	82.3 (14.12)	89.1 (13.77)	82.7 (10.99)
24 h	79.9 (11.19)	74.7 (12.58)	80.4 (11.32)	76.4 (12.06)
48 h	73.2 (11.28)	74.0 (11.02)	75.1 (10.32)	75.0 (9.46)
72 h	72.2 (10.63)	73.3 (9.16)	72.0 (7.99)	72.7 (8.78)
96 h	70.7 (10.64)	70.4 (9.11)	72.5 (10.12)	73.9 (9.86)

11. Secondary Outcome

Title	Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Description	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.
Time Frame	Pre-dose, 2 and 8 hours after dosing

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Vyvanse	Adderall XR	Vyvanse + Prilosec OTC	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	24	23	21	21
Pre-dose	399.8 (14.55)	398.3 (15.24)	399.3 (13.38)	399.8 (15.04)
2 h	395.0 (14.11)	394.6 (13.42)	397.9 (13.86)	396.1 (14.49)
8 h	390.0 (12.45)	393.8 (13.94)	395.4 (14.93)	394.4 (13.26)

12. Primary Outcome

Title	Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Description	l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

PK population

Arm/Group Title	Adderall XR	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	23	21
Mean (Standard Deviation) [ng/ml]	7.91 (2.022)	8.10 (1.632)

13. Primary Outcome

Title	Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Description	l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

PK population

Arm/Group Title	Adderall XR	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	23	21
Mean (Standard Deviation) [h]	5.6 (3.0)	3.5 (1.74)

14. Primary Outcome

Title	AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

PK population

Arm/Group Title	Adderall XR	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	23	21
Mean (Standard Deviation) [ng.h/ml]	145.28 (24.355)	145.83 (38.233)

15. Primary Outcome

Title	T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Description	l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

PK population

Arm/Group Title	Adderall XR	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	23	21
Mean (Standard Deviation) [h]	11.98 (1.92)	13.06 (2.63)

16. Primary Outcome

Title	Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Description	Total amphetamine is the d- and l-amphetamines.
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

PK population

Arm/Group Title	Adderall XR	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	23	21
Mean (Standard Deviation) [ng/ml]	36.56 (9.188)	38.05 (7.351)

17. Primary Outcome

Title	Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Description	Total amphetamine is the d- and l-amphetamines.
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

PK population

Arm/Group Title	Adderall XR	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	23	21
Mean (Standard Deviation) [h]	5.30 (3.07)	3.29 (1.45)

18. Primary Outcome

Title	AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Description	Total amphetamine is the d- and l-amphetamines.
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

PK population

Arm/Group Title	Adderall XR	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	23	21
Mean (Standard Deviation) [ng.h/ml]	620.68 (95.689)	620.91 (145.378)

19. Primary Outcome

Title	T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Description	Total amphetamine is the d- and l-amphetamines.
Time Frame	0 through 96 hours after dosing

Outcome Measure Data

Analysis Population Description

PK population

Arm/Group Title	Adderall XR	Adderall XR + Prilosec OTC
Arm/Group Description
Measure Participants	23	21
Mean (Standard Deviation) [h]	10.38 (1.56)	11.05 (2.22)

Adverse Events

Arm/Group Title	Vyvanse		Adderall XR		Vyvanse + Prilosec OTC		Adderall XR + Prilosec OTC
Arm/Group Description
All Cause Mortality
	Vyvanse		Adderall XR		Vyvanse + Prilosec OTC		Adderall XR + Prilosec OTC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Vyvanse		Adderall XR		Vyvanse + Prilosec OTC		Adderall XR + Prilosec OTC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/23 (0%)		0/21 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Vyvanse		Adderall XR		Vyvanse + Prilosec OTC		Adderall XR + Prilosec OTC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/24 (33.3%)		3/23 (13%)		10/21 (47.6%)		3/21 (14.3%)
Cardiac disorders
Palpitations	2/24 (8.3%)	2	1/23 (4.3%)	1	0/21 (0%)	0	0/21 (0%)	0
Tachycardia	2/24 (8.3%)	2	0/23 (0%)	0	0/21 (0%)	0	0/21 (0%)	0
Nervous system disorders
Dizziness	1/24 (4.2%)	1	0/23 (0%)	0	2/21 (9.5%)	2	0/21 (0%)	0
Headache	1/24 (4.2%)	1	0/23 (0%)	0	3/21 (14.3%)	3	0/21 (0%)	0
Psychiatric disorders
Anxiety	2/24 (8.3%)	2	2/23 (8.7%)	2	8/21 (38.1%)	9	0/21 (0%)	0
Vascular disorders
Vasospasm	0/24 (0%)	0	0/23 (0%)	0	4/21 (19%)	4	3/21 (14.3%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.