Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shire
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Age 18-65 years
Must be considered "healthy".
Serum ferritin \>20ng/mL, hemoglobin \>125g/L and erythrocyte indices within normal range
You may not be if
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.
Clareo Health | A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)
