SPD544 High Strength Bioequivalence Study

NCT01183234 | Completed Phase 1 Results

• 1 other identifier: SPD544-101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess bioequivalence of 2 capsule strengths.

Conditions

ADHD

Outcome Measures

Primary Outcomes (3)

• 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)

  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.

  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

• Maximum Plasma Concentration (Cmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)

  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.

  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

• Time of Maximum Plasma Concentration (Tmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)

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

  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

Study Arms (2)

SPD544 (Equasym XL)

EXPERIMENTAL

Drug: SPD544

Methylphenidate hydrochloride (Metadate CD )

EXPERIMENTAL

Drug: Methylphenidate hydrochloride

Interventions

SPD544 DRUG

two 30mg capsules, single oral dose

Also known as: Equasym XL

SPD544 (Equasym XL)

Methylphenidate hydrochloride DRUG

one 60mg capsule, single oral dose

Also known as: Metadate CD

Methylphenidate hydrochloride (Metadate CD )

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects, aged 18-55 years inclusive at the time of consent.
• Subject must be willing to comply with applicable contraceptive requirements of the protocol and be:
• Male, or
• Non-pregnant, non-lactating female who must be \>90 days post-partum or nulliparous.
• Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG, and clinical laboratory evaluation (haematology, biochemistry, urinalysis) as assessed by the Investigator.
• Ability to provide written, personally signed and dated informed consent to participate in the study.
• An understanding, ability and willingness to fully comply with study procedures and restrictions.
• Ability to swallow all investigational medicinal products (IMPs).

You may not qualify if:

• Current or recurrent disease (e.g., cardiovascular, renal, liver, gastrointestinal, malignancy or other conditions) that could affect the action, absorption, or disposition of the IMPs, or could affect clinical or laboratory assessments.
• Current or relevant 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 IMPs or study procedures.
• Current use of any medication (including prescription, over-the-counter \[OTC\], herbal, or homeopathic preparations) with the exception of hormone replacement therapy or hormonal contraceptives and/or an occasional dose of nonsteroidal anti-inflammatory (NSAID), or paracetamol (current use is defined as use within 14 days of first dose of IMP).
• History of hypertension or a resting sitting systolic blood pressure \>139mmHg or diastolic blood pressure \>89mmHg.
• History of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
• Known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischaemic attack or stroke, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
• Family history of sudden cardiac death or ventricular arrhythmia.
• Known cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or history of stroke.
• Diagnosis of glaucoma.
• Diagnosis of phaeochromocytoma.
• Current abnormal thyroid function, as defined as abnormal screening thyroid stimulating hormone (TSH) and thyroxine (T4).
• Current marked anxiety, tension and/or agitation.
• History of alcohol or other substance abuse within the last year.
• A positive screen for alcohol or drugs of abuse at Screening or Day -1 of Treatment Period 1.
• Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Paraxel International

London, United Kingdom

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 17, 2010
• Study Start: August 27, 2010
• Primary Completion: October 22, 2010
• Study Completion: October 22, 2010
• Last Updated: June 9, 2021
• Results First Posted: August 25, 2011

Record last verified: 2021-05

Locations

GB (1)