AN OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE RELATIVE BIOAVAILABILITY OF A NEW TABLET FORMULATION OF MINZASOLMIN AND THE POTENTIAL EFFECT OF FOOD ON THE PHARMACOKINETICS OF MINZASOLMIN IN HEALTHY PARTICIPANTS

Conditions

Healthy Participants

Brief summary

Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fasted conditions, Area under the plasma concentration-time curve from time 0 to t of minzasolmin granules in capsules under fasted conditions, Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fed conditions, Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fasted conditions, Area under the plasma concentration-time curve from zero to infinity of minzasolmin granules in capsules under fasted conditions, Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fed conditions, Maximum plasma concentration (Cmax) of minzasolmin tablets under fasted conditions, Maximum plasma concentration (Cmax) of minzasolmin granules in capsules under fasted conditions, Maximum plasma concentration (Cmax) of minzasolmin tablets under fed conditions

Detailed description

Occurrence of treatment-emergent adverse events (TEAEs), Occurrence of serious treatment-emergent adverse events (serious TEAEs), Occurrence of TEAEs leading to withdrawal from study

Related papers

No related papers found yet.

Interventions

DRUGMinzasolmin

DRUGUCB0599 PRD4385815

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fasted conditions, Area under the plasma concentration-time curve from time 0 to t of minzasolmin granules in capsules under fasted conditions, Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fed conditions, Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fasted conditions, Area under the plasma concentration-time curve from zero to infinity of minzasolmin granules in capsules under fasted conditions, Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fed conditions, Maximum plasma concentration (Cmax) of minzasolmin tablets under fasted conditions, Maximum plasma concentration (Cmax) of minzasolmin granules in capsules under fasted conditions, Maximum plasma concentration (Cmax) of minzasolmin tablets under fed conditions	—

Measure

Time frame

Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fasted conditions, Area under the plasma concentration-time curve from time 0 to t of minzasolmin granules in capsules under fasted conditions, Area under the plasma concentration-time curve from time 0 to t of minzasolmin tablets under fed conditions, Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fasted conditions, Area under the plasma concentration-time curve from zero to infinity of minzasolmin granules in capsules under fasted conditions, Area under the plasma concentration-time curve from zero to infinity of minzasolmin tablets under fed conditions, Maximum plasma concentration (Cmax) of minzasolmin tablets under fasted conditions, Maximum plasma concentration (Cmax) of minzasolmin granules in capsules under fasted conditions, Maximum plasma concentration (Cmax) of minzasolmin tablets under fed conditions

—

Secondary

Measure	Time frame
Occurrence of treatment-emergent adverse events (TEAEs), Occurrence of serious treatment-emergent adverse events (serious TEAEs), Occurrence of TEAEs leading to withdrawal from study	—

Countries

Germany

Outcome results

None listed