Phase 3
Completed N=35
Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers
Healthy Volunteers
Source: ClinicalTrials.gov NCT03010631 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite — 117.518; 163.615 h*pg/mL
◆ Published Evidence
Emerging
1citation · ~0 / year
Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation.
Summary
A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
Linked Publications
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Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite |
117.518; 163.615 | — |
| PRIMARY Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite |
63.463; 127.729 | — |
| SECONDARY Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition |
135.805; 152.900 | — |
| SECONDARY Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions |
48.192; 116.815 | — |
Eligibility Criteria
Inclusion Criteria
- Is male or female, between 18 and 55 years of age, inclusive.
- Has a 12-lead electrocardiogram (ECG) within normal limits and is in good health based upon review of medical history, physical examination results, vital signs (within normal range), and normal laboratory profile for both blood and urine.
Exclusion Criteria
- Has an active or recent history of alcoholism or drug addiction (within 1 year prior)
- Is a smoker or has a recent history of smoking (within 6 months)
- Routinely consumes food known to alter drug metabolism (i.e., grapefruit juice, coffee, tea, cola, chocolate, cocoa, or other caffeine or methyl-xanthine containing foods or beverages) and/or cannot refrain from these items
- Has donated blood within 3 months
- Has a medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
Data sourced from ClinicalTrials.gov (NCT03010631) and the linked publication. 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.