A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)

Completed · Phase 1

Conditions studied: Healthy

In brief

This study will evaluate the relative bioavailability of the new SSP-004184SS capsule formulation compared to the original SSP-004184AQ drug plus excipients formulation.

Key facts

Study ID

NCT01905540

Run by

Shire

People needed

28

Starts

2013-08-05

Expected to finish

2013-09-20

Last updated by the study team

2021-07-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify 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 qualify 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.

Where it is running

• Clinical Pharmacology of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.