Ursodiol 500 mg Tablets Under Fed Conditions

Phase 1

Completed

Brief Summary: 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.

Detailed Description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Ursodiol (test) First	Ursodiol	Ursodiol Tablets, 500 mg
Urso Forte™ (reference) First	Urso Forte™	Urso Forte™ Tablets, 500 mg

Primary Outcome Measures

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