Trial Outcomes & Findings for SPD544 High Strength Bioequivalence Study (NCT NCT01183234)

Last Updated: 2021-06-09

Results Overview

AUC 0-t is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose

Results posted on

2021-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Equasym XL (SPD544) First, Then Metadate CD Subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule)	Metadate CD First, Then Equasym XL Subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules)
First Intervention STARTED	14	14
First Intervention COMPLETED	13	14
First Intervention NOT COMPLETED	1	0
Washout STARTED	13	14
Washout COMPLETED	13	14
Washout NOT COMPLETED	0	0
Second Intervention STARTED	13	14
Second Intervention COMPLETED	13	14
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Equasym XL (SPD544) First, Then Metadate CD Subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule)	Metadate CD First, Then Equasym XL Subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules)
First Intervention Adverse Event	1	0

Baseline Characteristics

SPD544 High Strength Bioequivalence Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Equasym XL First, Then Metadate CD n=14 Participants Subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)	Metadate CD First, Then Equasym XL n=14 Participants Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules)	Total n=28 Participants Total of all reporting groups
Age, Customized	30.8 years STANDARD_DEVIATION 10.12 • n=99 Participants	29.5 years STANDARD_DEVIATION 8.61 • n=107 Participants	30.1 years STANDARD_DEVIATION 9.24 • n=206 Participants
Age, Customized 18 to 55 years	14 Participants n=99 Participants	14 Participants n=107 Participants	28 Participants n=206 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	7 Participants n=107 Participants	11 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	7 Participants n=107 Participants	17 Participants n=206 Participants
Region of Enrollment United Kingdom	14 Participants n=99 Participants	14 Participants n=107 Participants	28 Participants n=206 Participants

PRIMARY outcome

Timeframe: predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose

Population: Pharmacokinetic analysis set (PK) defined as all subjects in the safety analysis set who had evaluable plasma concentration-time profiles for MPH through 24 hours post-dosing in both treatment periods. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded.

Outcome measures

Outcome measures
Measure	Equasym XL n=27 Participants Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)	Metadate CD n=27 Participants Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
Area Under the Steady-state Plasma Concentration-time Curve (AUC 0-t) for Methylphenidate Hydrochloride (MPH) Using Two Different Formulations (Equasym XL and Metadate CD)	133 ng*h/ml Interval 122.0 to 145.0	127 ng*h/ml Interval 116.0 to 138.0

PRIMARY outcome

Timeframe: predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose

Population: PK set

Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

Outcome measures

Outcome measures
Measure	Equasym XL n=27 Participants Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)	Metadate CD n=27 Participants Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
Maximum Plasma Concentration (Cmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)	14.9 ng/ml Interval 13.8 to 16.1	14.7 ng/ml Interval 13.7 to 15.9

PRIMARY outcome

Timeframe: predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose

Population: PK set

Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.

Outcome measures

Outcome measures
Measure	Equasym XL n=27 Participants Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)	Metadate CD n=27 Participants Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
Time of Maximum Plasma Concentration (Tmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)	5.0 hours Interval 0.983 to 5.15	5.0 hours Interval 0.967 to 6.05

Adverse Events

Equasym XL

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Metadate CD

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Equasym XL n=28 participants at risk Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)	Metadate CD n=27 participants at risk Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
Gastrointestinal disorders Dry mouth	17.9% 5/28 Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	11.1% 3/27 Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Nervous system disorders Dizziness	10.7% 3/28 Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	7.4% 2/27 Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Nervous system disorders Headache	7.1% 2/28 Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	11.1% 3/27 Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Gastrointestinal disorders Nausea	7.1% 2/28 Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	7.4% 2/27 Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Psychiatric disorders Anxiety	3.6% 1/28 Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	7.4% 2/27 Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER