NCT03512808

Brief Summary

A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

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

June 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

April 19, 2018

Last Update Submit

May 2, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Maximum Plasma Concentration (Cmax)

    0-72 hours

  • Area under the plasma concentration versus time curve (AUC)

    0-72 hours

Study Arms (2)

Ursodiol 500mg tablets

EXPERIMENTAL

Ursodiol 500mg tablets followed by Urso Forte 500mg tablets

Drug: Ursodiol 500 MG

Urso Forte 500mg tablets

ACTIVE COMPARATOR

Urso forte 500mg tablets followed by Ursodiol 500mg tablets

Drug: Urso Forte 500Mg Tablet

Interventions

Ursodiol 500 MGDRUG

Ursodiol 500mg tablets followed by Urso Forte 500mg tablets

Ursodiol 500mg tablets
Urso Forte 500Mg TabletDRUG

Urso forte 500mg tablets followed by Ursodiol 500mg tablets

Urso Forte 500mg tablets

Eligibility Criteria

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

You may qualify if:

  • Healthy, non-smoking, male and female subjects, 18 years of age or older
  • BMI ≥ 19.0 and ≤ 30.0 kg/m2.
  • Females who participate in this study will be of chilbearing or non-childbearing potential

You may not qualify if:

  • Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharma medica research Inc.

Mississauga, Ontario, 6100, Canada

Location

MeSH Terms

Interventions

Ursodeoxycholic AcidTablets

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanesDosage FormsPharmaceutical Preparations

Study Design

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

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 1, 2018

Study Start

June 1, 2017

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

May 7, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)