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Completed

NCT Number: NCT03512808

A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fasting Conditions

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

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharma medica research Inc.

Mississauga, Ontario, 6100, Canada

About this study

A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ursodiol 500 MG

Drug

Ursodiol 500mg tablets followed by Urso Forte 500mg tablets

Urso Forte 500Mg Tablet

Drug

Urso forte 500mg tablets followed by Ursodiol 500mg tablets

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: 0-72 hours

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: 0-72 hours

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 1, 2018
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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