HealthyPhase 1NCT00909753

Ursodiol 500 mg Tablets Under Fed Conditions

A Phase 1 study testing Ursodiol and Urso Forte™ in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Ursodiol and Urso Forte™
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteCanada
Study dates: Sep 2006to Oct 2006
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

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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
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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Pharma Medica Research Inc.
Toronto, Ontario, M1R 5A3

Other trials in Canada

About this study

Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500 mg Tablets Under Fed Conditions

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions: Healthy
Being tested: Ursodiol, Urso Forte™
Keywords: Bioequivalence, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UrsodiolDrug
Ursodiol Tablets, 500 mg
Urso Forte™Drug
Urso Forte™ Tablets, 500 mg

Study groups in NCT00909753
Study group	Role	What they receive
Ursodiol (test) First	Experimental	Ursodiol Tablets, 500 mg Receives: Drug: Ursodiol
Urso Forte™ (reference) First	Active comparator	Urso Forte™ Tablets, 500 mg Receives: Drug: Urso Forte™

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Oct 2006

First posted28 May 2009 (estimated)
Study startSep 2006
Primary completionOct 2006
Study completionOct 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00909753
Sponsor's protocol ID: 2006-1284
Status last verified: Aug 2024
First submitted: 26 May 2009
Last updated: 19 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500 mg Tablets Under Fed Conditions
ClinicalTrials.gov ID: NCT00909753
Acronym / sponsor ID: 2006-1284
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Oct 2006 (actual)
Study completion: Oct 2006 (actual)
First posted: 28 May 2009 (estimated)
Results: Posted 21 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ursodiol (test) First	Experimental	Drug: UrsodiolUrsodiol Tablets, 500 mg
Urso Forte™ (reference) First	Active comparator	Drug: Urso Forte™Urso Forte™ Tablets, 500 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Healthy, non-smoking male and female subjects, 18 years of age or older.
BMI ≥ 19 and ≤ 30.
Negative for:
No significant diseases or clinically significant findings in a physical examination.
No clinically significant abnormal laboratory values.

Key exclusion criteria (16 listed)

Known history or presence of any clinically significant medical condition.
Known or suspected carcinoma.
Known history or presence of:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UrsodiolUrsodiol Tablets, 500 mg	Drug	Ursodiol (test) First
Urso Forte™Urso Forte™ Tablets, 500 mg	Drug	Urso Forte™ (reference) First

Primary outcome

Cmax - Maximum Observed Concentration - for Total Ursodiol
Time frame: 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
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-72
Cmax for Unconjugated Ursodiol
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on Cmax
AUC0-72 for Unconjugated Ursodiol
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-72
Cmax for Total Ursodiol - Baseline Corrected
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on Cmax
AUC0-72 for Total Ursodiol - Baseline Corrected
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-72
Cmax for Unconjugated Ursodiol - Baseline Corrected
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on Cmax
AUC0-72 for Unconjugated Ursodiol - Baseline Corrected
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-72

Results and safety

Results posted to the registry on 21 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ursodiol (Test) First	46	46
Urso Forte™ (Reference) First	46	46

Primary outcome: Cmax - Maximum Observed Concentration - for Total Ursodiol

Time frame: Blood samples collected over 72 hour period. Mean (Standard Deviation). Unit: ng/mL

Measure	Ursodiol n = 86	Urso Forte™ n = 86
Value	6763.805 (2305.341)	7461.161 (2922.024)

Ursodiol vs Urso Forte™: Geometric Test/Ref Ratio x 100: 92.5 (90% CI 85.8 to 99.7)

Population analysed: Data from all subjects who completed the study was included in the statistical analysis.

Primary outcome: AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post Dose - for Total Ursodiol

Time frame: Blood samples collected over 72 hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Ursodiol n = 86	Urso Forte™ n = 86
Value	84789.776 (33376.080)	87925.305 (30085.315)

Ursodiol vs Urso Forte™: Geometric Test/Ref Ratio x 100: 95.5 (90% CI 92.2 to 98.9)

Population analysed: Data from all subjects who completed the study was included in the statistical analysis.

Primary outcome: Cmax for Unconjugated Ursodiol

Time frame: Blood samples collected over 72 hour period. Mean (Standard Deviation). Unit: ng/mL

Measure	Ursodiol n = 86	Urso Forte™ n = 86
Value	5818.644 (2145.519)	6549.897 (2681.097)

Ursodiol vs Urso Forte™: Geometric Test/Ref Ratio x 100: 90.4 (90% CI 83.1 to 98.3)

Population analysed: Data from all subjects who completed the study was included in the statistical analysis.

Primary outcome: AUC0-72 for Unconjugated Ursodiol

Time frame: Blood samples collected over 72 hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Ursodiol n = 86	Urso Forte™ n = 86
Value	28543.339 (21022.046)	30951.831 (16492.541)

Ursodiol vs Urso Forte™: Geometric Test/Ref Ratio x 100: 90.5 (90% CI 85.5 to 95.9)

Population analysed: Data from all subjects who completed the study was included in the statistical analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Pharma Medica Research, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ursodiol and Urso Forte™ in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax - Maximum Observed Concentration - for Total Ursodiol (time frame: Blood samples collected over 72 hour period). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00909753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.