Healthy VolunteersPhase 1NCT00746733

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

A Phase 1 study testing Lisdexamfetamine Dimesylate and Adderall XR (mixed salts amphetamine) in people with Healthy Volunteers, run by Shire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Lisdexamfetamine Dimesylate and Adderall XR (mixed salts amphetamine)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 8 Sep 2008to 26 Oct 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers, age 18 to 45 inclusive at the time of consent.
Male, or non-pregnant, non-lactating female
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.
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.
Satisfactory medical assessment with no significant or relevant abnormality in medical history, physical examination (PE), vital signs and laboratory evaluation
Normal or clinically insignificant Screening ECG findings as assessed by the Investigator.
Ability to swallow investigational products.

Who cannot join

Current or recurrent disease that could affect the action, absorption or disposition of the investigational products, or could affect clinical or laboratory assessments.
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.
Significant illness, as judged by the Investigator, within 2 weeks of the first dose of investigational product.
History of significant anxiety, tension or agitation as assessed by the Investigator.
History of or current diagnosis of glaucoma.
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.

Show all 14Show fewer

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.
History of controlled or uncontrolled hypertension or a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg.
Known family history of sudden cardiac death or ventricular arrhythmia.
Currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation.
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).
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.
Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds or any of the stated ingredients.
History of alcohol or other substance abuse within the last year.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014

Other trials in United States

About this study

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

Conditions: Healthy Volunteers
Being tested: Lisdexamfetamine Dimesylate, Adderall XR (mixed salts amphetamine)
Keywords: Drug, Interaction, Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lisdexamfetamine DimesylateDrug
50mg capsule
Adderall XR (mixed salts amphetamine)Drug
20mg capsule

Study groups in NCT00746733
Study group	Role	What they receive
Vyvanse (LDX)	Experimental	Not described Receives: Drug: Lisdexamfetamine Dimesylate
Adderall XR (AXR)	Experimental	Not described Receives: Drug: Adderall XR (mixed salts amphetamine)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Pre-dose, 2 and 8 hours after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 200826 Oct 2008

First posted4 Sep 2008 (estimated)
Study start8 Sep 2008
Primary completion26 Oct 2008
Study completion26 Oct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00746733
Sponsor's protocol ID: SPD489-113
Status last verified: Jun 2021
First submitted: 2 Sep 2008
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 19820270
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.
PubMed 21474905

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00746733
Acronym / sponsor ID: SPD489-113
Conditions: Healthy Volunteers
Keywords: Drug, Interaction, Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 8 Sep 2008 (actual)
Primary completion: 26 Oct 2008 (actual)
Study completion: 26 Oct 2008 (actual)
First posted: 4 Sep 2008 (estimated)
Results: Posted 17 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Vyvanse (LDX)	Experimental	Drug: Lisdexamfetamine Dimesylate
Adderall XR (AXR)	Experimental	Drug: Adderall XR (mixed salts amphetamine)

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Healthy volunteers, age 18 to 45 inclusive at the time of consent.
Male, or non-pregnant, non-lactating female
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.
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.
Satisfactory medical assessment with no significant or relevant abnormality in medical history, physical examination (PE), vital signs and laboratory evaluation

Key exclusion criteria (14 listed)

Current or recurrent disease that could affect the action, absorption or disposition of the investigational products, or could affect clinical or laboratory assessments.
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.
Significant illness, as judged by the Investigator, within 2 weeks of the first dose of investigational product.
History of significant anxiety, tension or agitation as assessed by the Investigator.
History of or current diagnosis of glaucoma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lisdexamfetamine Dimesylate50mg capsule	Drug	Vyvanse (LDX)
Adderall XR (mixed salts amphetamine)20mg capsule	Drug	Adderall XR (AXR)

Primary outcome

Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Time frame: 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.
Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Time frame: 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.
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
Time frame: 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.
Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Time frame: 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.
Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Time frame: 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.
Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Time frame: 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.
AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Time frame: 0 through 96 hours after dosing
T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Time frame: 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.
Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Time frame: 0 through 96 hours after dosing
Total amphetamine is the d- and l-amphetamines.
Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Time frame: 0 through 96 hours after dosing
Total amphetamine is the d- and l-amphetamines.
AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Time frame: 0 through 96 hours after dosing
Total amphetamine is the d- and l-amphetamines.
T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
Time frame: 0 through 96 hours after dosing
Total amphetamine is the d- and l-amphetamines.

7 secondary outcomes

Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
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
DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
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
DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
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
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
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
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
Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
Time frame: Pre-dose, 2 and 8 hours after dosing

Results and safety

Results posted to the registry on 17 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vyvanse First	12	12
Adderall XR First	12	12

Primary outcome: Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

Time frame: 0 through 96 hours after dosing. Mean (Standard Deviation). Unit: ng/ml

Measure	Vyvanse n = 24	Adderall XR n = 23	Vyvanse + Prilosec OTC n = 21	Adderall XR + Prilosec OTC n = 21
Value	45.04 (13.971)	28.66 (7.174)	46.34 (9.710)	29.97 (5.719)

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

Primary outcome: Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

Time frame: 0 through 96 hours after dosing. Mean (Standard Deviation). Unit: h

Measure	Vyvanse n = 24	Adderall XR n = 23	Vyvanse + Prilosec OTC n = 21	Adderall XR + Prilosec OTC n = 21
Value	3.5 (1.14)	5.2 (3.10)	3.5 (0.97)	3.3 (1.45)

Population analysed: PK population

Primary outcome: 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

Time frame: 0 through 96 hours after dosing. Mean (Standard Deviation). Unit: ng.h/ml

Measure	Vyvanse n = 24	Adderall XR n = 23	Vyvanse + Prilosec OTC n = 21	Adderall XR + Prilosec OTC n = 21
Value	626.27 (198.982)	473.70 (71.043)	687.00 (196.906)	472.35 (108.891)

Population analysed: PK population

Primary outcome: Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

Time frame: 0 through 96 hours after dosing. Mean (Standard Deviation). Unit: h

Measure	Vyvanse n = 24	Adderall XR n = 23	Vyvanse + Prilosec OTC n = 21	Adderall XR + Prilosec OTC n = 21
Value	9.7 (1.55)	10.25 (1.36)	10.4 (1.65)	10.91 (1.95)

Population analysed: PK population

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vyvanse	0 of 24 (0%)	8 of 24 (33.3%)	Not reported
Adderall XR	0 of 23 (0%)	3 of 23 (13%)	Not reported
Vyvanse + Prilosec OTC	0 of 21 (0%)	10 of 21 (47.6%)	Not reported
Adderall XR + Prilosec OTC	0 of 21 (0%)	3 of 21 (14.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19820270Haffey 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.
Derived from this study: PubMed 21474905Wigal 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.
FDA recall informationLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lisdexamfetamine Dimesylate and Adderall XR (mixed salts amphetamine) in people with Healthy Volunteers, run by Shire at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (time frame: 0 through 96 hours after dosing). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00746733, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.