Ursodiol 500 mg Tablets Under Fed Conditions

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

The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference)after a single-dose in healthy subjects under fed conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ursodiol; Drug: Urso Forte™

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M1R 5A3
      • Pharma Medica Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy, non-smoking male and female subjects, 18 years of age or older.
• BMI ≥ 19 and ≤ 30.

• Negative for:

  1. HIV.
  2. Hepatitis B surface antigen and Hepatitis C antibody.
  3. Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
  4. Urine cotinine test
  5. Serum HCG consistent with pregnancy (females only)
• No significant diseases or clinically significant findings in a physical examination.
• No clinically significant abnormal laboratory values.
• No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
• Be informed of the nature of the study and given written consent prior to receiving any study procedure.

• Females who participate in this study are:

  1. unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy) OR
  2. willing to remain abstinent [not engage in sexual intercourse] OR
  3. willing to use an effective method of double-barrier birth control (e.g. partner using condom and female using diaphragm, contraceptive sponge, spermicide or IUD)
• Females who participate in this study are not pregnant and/or non-lactating.

Exclusion Criteria:

• Known history or presence of any clinically significant medical condition.
• Known or suspected carcinoma.

• Known history or presence of:

  1. Hypersensitivity or idiosyncratic reaction to ursodiol and/or any other drug substances with similar activity.
  2. Alcoholism within the last 12 months.
  3. Drug dependence and/or substance abuse.
  4. Use of tobacco or nicotine-containing products within the last 6 months.
• On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
• Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
• Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 499 mL of blood in the previous 45 days OR Donated more than 499 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
• Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
• Females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
• Requirement of any non-topical medication (prescription and/or over-the-counter, with systemic absorption) on a routine basis.
• Difficulty fasting or consuming the standard meals.
• Do not tolerate venipuncture.
• Unable to read or sign the ICF.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ursodiol (test) First; Ursodiol Tablets, 500 mg	Drug: Ursodiol; Ursodiol Tablets, 500 mg
Active Comparator: Urso Forte™ (reference) First; Urso Forte™ Tablets, 500 mg	Drug: Urso Forte™; Urso Forte™ Tablets, 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax - Maximum Observed Concentration - for Total Ursodiol	Bioequivalence based on Cmax	Blood samples collected over 72 hour period
Cmax for Unconjugated Ursodiol	Bioequivalence based on Cmax	Blood samples collected over 72 hour period
AUC0-72 for Unconjugated Ursodiol	Bioequivalence based on AUC0-72	Blood samples collected over 72 hour period
Cmax for Unconjugated Ursodiol - Baseline Corrected	Bioequivalence based on Cmax	Blood samples collected over 72 hour period
AUC0-72 for Unconjugated Ursodiol - Baseline Corrected	Bioequivalence based on AUC0-72	Blood samples collected over 72 hour period
AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post Dose - for Total Ursodiol	Bioequivalence based on AUC0-72	Blood samples collected over 72 hour period
Cmax for Total Ursodiol - Baseline Corrected	Bioequivalence based on Cmax	Blood samples collected over 72 hour period
AUC0-72 for Total Ursodiol - Baseline Corrected	Bioequivalence based on AUC0-72	Blood samples collected over 72 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Xueyu (Eric) Chen, MD, PhD, FRCP(C), Pharma Medica Research, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: May 26, 2009
• First Submitted That Met QC Criteria: May 27, 2009
• First Posted (Estimated): May 28, 2009

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Gastrointestinal Agents; Cholagogues and Choleretics; Ursodeoxycholic Acid
• Other Study ID Numbers: 2006-1284