Clinical trial NCT00909610: Ursodiol Tablets 500 mg Under Fasting Conditions
Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility 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.

Primary outcomes:
measure: Cmax - Maximum Observed Concentration - for Total Ursodiol
timeFrame: Blood samples collected over 72 hour period
measure: AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours - for Total Ursodiol
timeFrame: Blood samples collected over 72 hour period
measure: Cmax for Baseline Corrected Total Ursodiol
timeFrame: Blood samples collected over 72 hour period
measure: AUC0-72 for Baseline Corrected Total Ursodiol
timeFrame: Blood samples collected over 72 hour period
measure: Cmax for Unconjugated Ursodiol
timeFrame: Blood samples collected over 72 hour period
measure: AUC0-72 for Unconjugated Ursodiol
timeFrame: Blood samples collected over 72 hour period
measure: Cmax for Unconjugated Ursodiol - Baseline Corrected
timeFrame: Blood samples collected over 72 hour period
measure: AUC0-72 for Unconjugated Ursodiol - Baseline Corrected
timeFrame: Blood samples collected over 72 hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Pharma Medica Research Inc.
state: Ontario
Study officials:
affiliation: Pharma Medica Research, Inc.
name: Xueyu (Eric) Chen, MD, PhD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References: