Phase 1
Completed N=28
A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)
Healthy
Source: ClinicalTrials.gov NCT01905540 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose — 261901.9; 164340 ng*h/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose |
261901.9; 164340 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose |
263911.3; 164614.8 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose |
110114.3; 77068.6 | — |
| SECONDARY Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses |
545957; 294186.8 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses |
546114.1; 294758.5 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses |
112558.3; 77958.3; 73776.9; 43015.4 | — |
Eligibility 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 or 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.
Data sourced from ClinicalTrials.gov (NCT01905540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.