HealthyPhase 1NCT03512808
A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fasting Conditions
A Phase 1 study testing Ursodiol 500 MG and Urso Forte 500Mg Tablet in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in Canada.
Trial summary
A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting 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 500 MG and Urso Forte 500Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 31 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 ≥ 19.0 and ≤ 30.0 kg/m2.
- Females who participate in this study will be of chilbearing or non-childbearing potential
Who cannot join
- Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
Trial locations and contacts
1 site in 1 country.
About this study
A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions
Read the detailed description
A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
- Conditions
- Healthy
- Being tested
- Ursodiol 500 MG, Urso Forte 500Mg Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodiol 500 MGDrug
Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
Urso Forte 500Mg TabletDrug
Urso forte 500mg tablets followed by Ursodiol 500mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Ursodiol 500mg tablets | Experimental | Ursodiol 500mg tablets followed by Urso Forte 500mg tablets Receives: Drug: Ursodiol 500 MG |
| Urso Forte 500mg tablets | Active comparator | Urso forte 500mg tablets followed by Ursodiol 500mg tablets Receives: Drug: Urso Forte 500Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Measured: 0-72 hours
Area under the plasma concentration versus time curve (AUC)
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Jun 2017
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512808
- Sponsor's protocol ID
- 2016-4052
- Status last verified
- May 2018
- First submitted
- 19 Apr 2018
- Last updated
- 7 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. 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 500mg Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03512808
- Acronym / sponsor ID
- 2016-4052
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions
Detailed description
A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ursodiol 500mg tablets | Experimental | Drug: Ursodiol 500 MGUrsodiol 500mg tablets followed by Urso Forte 500mg tablets |
| Urso Forte 500mg tablets | Active comparator | Drug: Urso Forte 500Mg TabletUrso forte 500mg tablets followed by Ursodiol 500mg tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy, non-smoking, male and female subjects, 18 years of age or older
- BMI ≥ 19.0 and ≤ 30.0 kg/m2.
- Females who participate in this study will be of chilbearing or non-childbearing potential
Key exclusion criteria (1 listed)
- Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
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 |
|---|---|---|
| Ursodiol 500 MGUrsodiol 500mg tablets followed by Urso Forte 500mg tablets | Drug | Ursodiol 500mg tablets |
| Urso Forte 500Mg TabletUrso forte 500mg tablets followed by Ursodiol 500mg tablets | Drug | Urso Forte 500mg tablets |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: 0-72 hours
Area under the plasma concentration versus time curve (AUC)
Time frame: 0-72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 500 MG and Urso Forte 500Mg Tablet in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. 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 3 inclusion and 1 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 7 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Plasma Concentration (Cmax) (time frame: 0-72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2018.