NCT02385032

Brief Summary

The purpose of this study is to evaluate bioavailability of two formulations of ursodiol.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

28 days

First QC Date

March 4, 2015

Last Update Submit

May 5, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUClast

    72 hours

  • Cmax

    72 hours

Study Arms (2)

AB

EXPERIMENTAL

Ursodiol followed by URSO Forte

Drug: UrsodiolDrug: URSO Forte

BA

EXPERIMENTAL

URSO Forte followed by Ursodiol

Drug: UrsodiolDrug: URSO Forte

Interventions

UrsodiolDRUG
ABBA
URSO ForteDRUG
ABBA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 19.0 and ≤ 30.0 kg/m2.
  • No clinically significant findings in a 12-lead electrocardiogram (ECG)
  • Be informed of the nature of the study and give written consent prior to any study procedure

You may not qualify if:

  • Known history or presence of any clinically significant medical condition
  • Participated in a clinical trial which involved administration of an investigational medicinal product within 30 days prior to drug administration, or recently participated in a clinical investigation that, in the opinion of the investigator, would jeopardize subject safety or the integrity of the study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 11, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

May 7, 2015

Record last verified: 2015-05