Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Sequence 1	Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
Sequence 2	Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
Sequence 3	Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
Sequence 4	Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
Sequence 5	Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
Sequence 6	Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention

Participant Flow for 3 periods

Period 1:   First Intervention

	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6
STARTED	5	5	5	5	5	5
COMPLETED	5	5	5	5	5	5
NOT COMPLETED	0	0	0	0	0	0

Period 2:   Second Intervention

	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6
STARTED	5	5	5	5	5	5
COMPLETED	5	5	5	5	5	5
NOT COMPLETED	0	0	0	0	0	0

Period 3:   Third Intervention

	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6
STARTED	5	5	5	5	5	5
COMPLETED	5	4	5	5	5	5
NOT COMPLETED	0	1	0	0	0	0
Withdrawal by Subject	0	1	0	0	0	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Sequence 1	Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
Sequence 2	Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
Sequence 3	Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
Sequence 4	Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
Sequence 5	Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
Sequence 6	Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
Total	Total of all reporting groups

Baseline Measures

	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6	Total
Overall Participants Analyzed  [Units: Participants]	5	5	5	5	5	5	30
Age  [Units: Years] Mean (Standard Deviation)	32.6  (10.16)	35.4  (12.42)	42.2  (4.44)	34.2  (12.42)	39.6  (9.86)	41.8  (10.06)	37.6  (10.07)
Age, Customized  [Units: Participants]
Between 18 and 65 years, inclusive	5	5	5	5	5	5	30
Gender  [Units: Participants]
Female	1	2	1	0	2	2	8
Male	4	3	4	5	3	3	22
Region of Enrollment  [Units: Participants]
UNITED STATES	5	5	5	5	5	5	30

1.  Primary:

Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate   [ Time Frame: Up to 96 hours post-dose ]

2.  Primary:

Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate   [ Time Frame: Up to 96 hours post-dose ]

3.  Primary:

AUC for D-amphetamine   [ Time Frame: Up to 96 hours post-dose ]

4.  Primary:

Cmax for D-amphetamine   [ Time Frame: Up to 96 hours-post-dose ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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