Phase 1 Completed N=30 Randomized Other

Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects

Healthy

Source: ClinicalTrials.gov NCT01989169 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcomePrimary: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Midazolam — 103.348; 120.1 ng*hr/mL

Summary

A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in Healthy Adult Subjects

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Midazolam	103.348; 120.1	—
PRIMARY Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Midazolam	100.935; 116.902	—
PRIMARY Maximum Plasma Concentration (Cmax) of Midazolam	35.124; 48.29	—

Eligibility Criteria

Inclusion Criteria

Normal healthy male and female volunteers between the ages of 18 and 65, inclusive
Serum ferritin, hemoglobin and erythrocyte indices within normal range

Exclusion Criteria

Evidence of any active or chronic disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01989169). 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.