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

• Status: Completed
• Trial end date: 2013-09-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shire

Criteria

Inclusion Criteria:

• Age 18-65 years

• Must be considered "healthy".

• Serum ferritin >20ng/mL, hemoglobin >125g/L and erythrocyte indices within normal range

Exclusion Criteria:

• 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.