Status:
COMPLETED
A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)
Lead Sponsor:
Shire
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will evaluate the relative bioavailability of the new SSP-004184SS capsule formulation compared to the original SSP-004184AQ drug plus excipients formulation.
Eligibility Criteria
Inclusion
- Age 18-65 years
- Must be considered "healthy".
- Serum ferritin \>20ng/mL, hemoglobin \>125g/L and erythrocyte indices within normal range
Exclusion
- Subject has a clinically significant history or a disorder detected during the medical interview/physical examination at the Screening Visit or any other medical condition that is capable of altering the absorption, metabolism, or elimination of drugs
- Acute illness, as judged by the investigator, within 2 weeks of Day 1 of Treatment Period 1.
- Known or suspected intolerance or hypersensitivity to the investigational products, closely related compounds, or any of the stated ingredients.
- Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months
- History of alcohol or other substance abuse within the last year.
- A positive screen for alcohol or drugs of abuse at the Screening Visit.
- Confirmed systolic blood pressure \>139mmHg or \<89mmHg, and diastolic blood pressure \>89mmHg or \<49mmHg.
- Twelve-lead ECG demonstrating QTc \>450msec at screening.
- Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches.
- Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
- A positive HIV antibody screen, HBsAg, or HCV antibody screen.
- Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch) within 30 days prior to Day 1 of Treatment Period 1.
Key Trial Info
Start Date :
August 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01905540
Start Date
August 5 2013
End Date
September 20 2013
Last Update
July 19 2021
Active Locations (1)
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1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014