SPD544 High Strength Bioequivalence Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01183234
First received: August 16, 2010
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
ADHD
Drug: SPD544
Drug: Methylphenidate hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1,Randomized,Open-Label,Two Period Single Dose Crossover Bioequivalence Study of Two Capsule Strengths of SPD544 In Healthy Volunteers.

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Maximum Plasma Concentration (Cmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Time of Maximum Plasma Concentration (Tmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.


Enrollment: 28
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD544 (Equasym XL) Drug: SPD544
two 30mg capsules, single oral dose
Other Name: Equasym XL
Experimental: Methylphenidate hydrochloride (Metadate CD ) Drug: Methylphenidate hydrochloride
one 60mg capsule, single oral dose
Other Name: Metadate CD

Detailed Description:

This will be a randomised, open-label, two-period, single dose, crossover bioequivalence study in healthy subjects under fasting conditions to assess bioequivalence of 1 x 60 mg capsule methylphenidate compared to 2 x 30 mg capsules methylphenidate. Pharmacokinetics and safety will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy subjects, aged 18-55 years inclusive at the time of consent.
  2. 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.
  3. Body Mass Index (BMI) between 18.5 and 30.0kg/m² inclusive. This inclusion criterion will only be assessed at the Screening visit.
  4. 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.
  5. Ability to provide written, personally signed and dated informed consent to participate in the study.
  6. An understanding, ability and willingness to fully comply with study procedures and restrictions.
  7. Ability to swallow all investigational medicinal products (IMPs).

Exclusion criteria:

  1. 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.
  2. 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.
  3. 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).
  4. History of hypertension or a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg.
  5. History of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
  6. 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.
  7. Family history of sudden cardiac death or ventricular arrhythmia.
  8. Known cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or history of stroke.
  9. Diagnosis of glaucoma.
  10. Diagnosis of phaeochromocytoma.
  11. Current abnormal thyroid function, as defined as abnormal screening thyroid stimulating hormone (TSH) and thyroxine (T4).
  12. Current marked anxiety, tension and/or agitation.
  13. History of alcohol or other substance abuse within the last year.
  14. A positive screen for alcohol or drugs of abuse at Screening or Day -1 of Treatment Period 1.
  15. Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
  16. A positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody screen.
  17. Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch) within 30 days prior to the Screening visit.
  18. Routine consumption of more than 300mg of caffeine per day or subjects who experience caffeine withdrawal headaches or have a history of caffeine withdrawal headaches.
  19. Donation of blood or blood products (e.g., plasma or platelets) within 90 days prior to the first dose of IMP.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183234

Locations
United Kingdom
Paraxel International
London, United Kingdom
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Dr. Muna Albayaty Paraxel International
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01183234     History of Changes
Other Study ID Numbers: SPD544-101
Study First Received: August 16, 2010
Results First Received: July 27, 2011
Last Updated: August 31, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014