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Ursodiol Tablets 500 mg Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00909610
First received: May 26, 2009
Last updated: August 14, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: Ursodiol
Drug: Urso Forte™
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500 mg Tablets Under Fasting Conditions

Resource links provided by NLM:

Drug Information available for: Ursodiol
U.S. FDA Resources

Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration - for Total Ursodiol [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours - for Total Ursodiol [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • Cmax for Baseline Corrected Total Ursodiol [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • AUC0-72 for Baseline Corrected Total Ursodiol [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • Cmax for Unconjugated Ursodiol [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • AUC0-72 for Unconjugated Ursodiol [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • Cmax for Unconjugated Ursodiol - Baseline Corrected [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • AUC0-72 for Unconjugated Ursodiol - Baseline Corrected [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ursodiol (test) First
Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg dosed in second period.
 Drug: Ursodiol
Ursodiol Tablets, 500 mg
Active Comparator: Urso Forte™ (reference) First
Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
 Drug: Urso Forte™
Urso Forte™ Tablets, 500 mg

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909610

Locations
Canada, Ontario
Pharma Medica Research Inc.
Toronto, Ontario, Canada, M1R 5A3
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Xueyu (Eric) Chen, MD, PhD, FRCP(C) Pharma Medica Research Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00909610     History of Changes
Other Study ID Numbers: 2006-1283
Study First Received: May 26, 2009
Results First Received: June 12, 2009
Last Updated: August 14, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013