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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-05

Study Completion Date

2013-09-20

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SSP-004184AQ (single dose)

40 mg/kg (oral capsule form) given once on Day 1

Group Type EXPERIMENTAL

SSP-004184AQ

Intervention Type DRUG

Magnesium salt

SSP-004184SS (single dose)

21.8 mg/kg (oral capsule form) given once on Day 1

Group Type EXPERIMENTAL

SSP-004184SS

Intervention Type DRUG

Disodium salt

SSP-004184AQ (2 doses)

40 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1

Group Type EXPERIMENTAL

SSP-004184AQ

Intervention Type DRUG

Magnesium salt

SSP-004184SS (2 doses)

21.8 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1

Group Type EXPERIMENTAL

SSP-004184SS

Intervention Type DRUG

Disodium salt

Interventions

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SSP-004184AQ

Magnesium salt

Intervention Type DRUG

SSP-004184SS

Disodium salt

Intervention Type DRUG

Other Intervention Names

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SPD602 SPD602

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes