Ursodiol Tablets 500 mg Under Fasting Conditions

NCT ID: NCT00909610

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2007-01-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ursodiol (test) First

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

Group Type: EXPERIMENTAL

Ursodiol

Intervention Type: DRUG

Ursodiol Tablets, 500 mg

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.

Group Type: ACTIVE_COMPARATOR

Urso Forte™

Intervention Type: DRUG

Urso Forte™ Tablets, 500 mg

Interventions

Ursodiol

Ursodiol Tablets, 500 mg

Intervention Type: DRUG

Urso Forte™

Urso Forte™ Tablets, 500 mg

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Xueyu (Eric) Chen, MD, PhD, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

Pharma Medica Research, Inc.

Locations

Pharma Medica Research Inc.

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

2006-1283

Identifier Type: -

Identifier Source: org_study_id