Ursodiol Tablets 500 mg Under Fasting Conditions

Study Overview
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Brief Summary
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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 fasting conditions.

Detailed Description
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Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ursodiol
* Drug: Urso Forte™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, non-smoking male and female subjects, 18 years of age or older. BMI ≥ 19 and ≤ 30. Negative for: HIV. Hepatitis B surface antigen and Hepatitis C antibody. Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone). Urine cotinine test 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: unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy) OR willing to remain abstinent [not engage in sexual intercourse] OR 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: Hypersensitivity or idiosyncratic reaction to ursodiol and/or any other drug substances with similar activity. Alcoholism within the last 12 months. Drug dependence and/or substance abuse. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ursodiol (test) First<br>Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg dosed in second period. | Drug: Ursodiol<br>* Ursodiol Tablets, 500 mg<br>|
| Active Comparator: Urso Forte™ (reference) First<br>Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period. | Drug: Urso Forte™<br>* Urso Forte™ Tablets, 500 mg<br>|

What is the study measuring?
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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 | 
| AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours - for Total Ursodiol | Bioequivalence based on AUC0-72 | Blood samples collected over 72 hour period | 
| Cmax for Baseline Corrected Total Ursodiol | Bioequivalence based on Cmax | Blood samples collected over 72 hour period | 
| AUC0-72 for Baseline Corrected Total Ursodiol | Bioequivalence based on AUC0-72 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Healthy Subjects