Ursodiol Tablets 500 mg Under Fasting Conditions

NCT00909610 | Completed Phase 1 Results

• 1 other identifier: 2006-1283
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Ursodiol (test) First

EXPERIMENTAL

Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg dosed in second period.

Drug: Ursodiol

Urso Forte™ (reference) First

ACTIVE COMPARATOR

Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.

Drug: Urso Forte™

Interventions

Ursodiol DRUG

Ursodiol Tablets, 500 mg

Ursodiol (test) First

Urso Forte™ DRUG

Urso Forte™ Tablets, 500 mg

Urso Forte™ (reference) First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Pharma Medica Research Inc.

Toronto, Ontario, M1R 5A3, Canada

Location

MeSH Terms

Interventions

Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: TEVA Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Xueyu (Eric) Chen, MD, PhD, FRCP(C)

  Pharma Medica Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2009
• First Posted: May 28, 2009
• Study Start: December 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: August 19, 2024
• Results First Posted: July 21, 2009

Record last verified: 2024-08

Locations

CA (1)