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PK and Food-Effect of Lubiprostone Sprinkle in Healthy Volunteers
NCT03010631Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2016
- Primary completion
- Dec 2016
- Countries
- 1
- Sponsor
- Sucampo
- Modality
- Orthosteric Ligands
- Drugs
- cobiprostone
- Conditions
- constipation
01
Overview
Phase 3, randomised, open-label trial of cobiprostone in constipation (4 cohorts), sponsored by Sucampo. Primary endpoints: Area Under the Concentration-time Curve From Hour 0 to the Last Measurable Concentration of M3 Metabolite at 1 day and Maximum Observed Concentration of M3 Metabolite at 1 day. Started Nov 2016; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
Cohort 1: Capsule -> Sprinkle
Capsule Fasted then Sprinkle Fasted
Cohort 1: Sprinkle -> Capsule
Sprinkle Fasted then Capsule Fasted
Cohort 2: Fed -> Fasted
Sprinkle Fed then Sprinkle Fasted
Cohort 2: Fasted -> Fed
Sprinkle Fasted then Sprinkle Fed
03
Who it enrols
Healthy volunteers aged 18-55 with normal ECG and lab profiles. Excludes smokers, recent alcohol/drug abuse, and those consuming caffeine/methyl-xanthine foods.
04
Endpoints
Primary
Area Under the Concentration-time Curve From Hour 0 to the Last Measurable Concentration of M3 Metabolite
Maximum Observed Concentration of M3 Metabolite
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