HealthyPhase 1NCT02181907
Bioequivalence Study of UH-AC 62 XX Tablets Compared With the Capsule Formulations in Healthy Volunteers
A Phase 1 study testing UH-AC 62 XX tablet and UH-AC 62 XX capsule in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX capsules 10 mg by single administration in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- UH-AC 62 XX tablet and UH-AC 62 XX capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Apr 2003
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 20 and ≤ 35 years
- Weight : Body Mass Index ≥ 18.5 and < 25
- Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test
- Subjects who volunteer to participate and are able to fully understand and agree to this study by written informed consent
Who cannot join
- History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
- History of hypersensitivity to UH-AC 62 XX (meloxicam) or salicylate (aspirin etc.) or Non-steroidal anti-inflammatory drugs (NSAIDs)
- History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
- A tendency of bleeding
- History of alcohol or drug abuse
- Taking an investigational drug within 4 months prior to the trial
Show all 14Show fewer
- Whole blood donation more than 400 mL within 3 months prior to the trial
- Whole blood donation more than 100 mL within 1 month prior to the trial
- Donation of constituent of blood of more than 400 mL within 1 month prior to the trial
- Any medication which could influence the results of the trial within 10 days prior to the trial
- Excessive physical activities within 7 days prior to the trial
- Alcohol drinking within 3 days prior to the trial
- History of orthostatic hypotension, fainting spells or blackouts
- Other than above, those who were judged by the investigator to be inappropriate as the subjects of the study
About this study
Official title: Bioequivalence Study of UH-AC 62 XX Tablets 10 mg (TF4) Compared With the 10 mg Capsule Formulations Following Single Peroral Administration in Healthy Volunteers
Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX capsules 10 mg by single administration in healthy volunteers.
- Conditions
- Healthy
- Being tested
- UH-AC 62 XX tablet, UH-AC 62 XX capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UH-AC 62 XX tabletDrug
UH-AC 62 XX capsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| UH-AC 62 XX tablet | Experimental | Not described Receives: Drug: UH-AC 62 XX tablet; Drug: UH-AC 62 XX capsule |
| UH-AC 62 XX capsule | Active comparator | Not described Receives: Drug: UH-AC 62 XX tablet; Drug: UH-AC 62 XX capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum observed concentration of the analyte in plasma)
Measured: up to 60 hours after drug administration
AUC 0-60hr (Area under the concentration time curve of the analyte in plasma from zero time to 60 hours)
Measured: up to 60 hours after drug administration
Secondary outcomes (5)
Tmax (Time to reach Cmax)
Measured: up to 60 hours after drug administration
t1/2 ( Terminal half-life of the analyte in plasma)
Measured: up to 60 hours after drug administration
AUC 0-infinity (Area under the concentration time curve of the analyte in plasma from zero time to infinity)
Measured: up to 60 hours after drug administration
MRTpo (Mean residence time of the analyte in the body after single dose po administration)
Measured: up to 60 hours after drug administration
Number of patients with adverse events
Measured: up to 20 days after final drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMar 2003
- Primary completionApr 2003
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.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181907
- Sponsor's protocol ID
- 107.260
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of UH-AC 62 XX Tablets 10 mg (TF4) Compared With the 10 mg Capsule Formulations Following Single Peroral Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02181907
- Acronym / sponsor ID
- 107.260
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Apr 2003 (actual)
- First posted
- 8 Jul 2014 (estimated)
- 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.
Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX capsules 10 mg by single administration in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UH-AC 62 XX tablet | Experimental | Drug: UH-AC 62 XX tablet, Drug: UH-AC 62 XX capsule |
| UH-AC 62 XX capsule | Active comparator | Drug: UH-AC 62 XX tablet, Drug: UH-AC 62 XX capsule |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ≥ 20 and ≤ 35 years
- Weight : Body Mass Index ≥ 18.5 and < 25
- Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test
- Subjects who volunteer to participate and are able to fully understand and agree to this study by written informed consent
Key exclusion criteria (14 listed)
- History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
- History of hypersensitivity to UH-AC 62 XX (meloxicam) or salicylate (aspirin etc.) or Non-steroidal anti-inflammatory drugs (NSAIDs)
- History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
- A tendency of bleeding
- History of alcohol or drug abuse
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 |
|---|---|---|
| UH-AC 62 XX tablet | Drug | UH-AC 62 XX capsule, UH-AC 62 XX tablet |
| UH-AC 62 XX capsule | Drug | UH-AC 62 XX capsule, UH-AC 62 XX tablet |
Primary outcome
Cmax (Maximum observed concentration of the analyte in plasma)
Time frame: up to 60 hours after drug administration
AUC 0-60hr (Area under the concentration time curve of the analyte in plasma from zero time to 60 hours)
Time frame: up to 60 hours after drug administration
5 secondary outcomes
Tmax (Time to reach Cmax)
Time frame: up to 60 hours after drug administration
t1/2 ( Terminal half-life of the analyte in plasma)
Time frame: up to 60 hours after drug administration
AUC 0-infinity (Area under the concentration time curve of the analyte in plasma from zero time to infinity)
Time frame: up to 60 hours after drug administration
MRTpo (Mean residence time of the analyte in the body after single dose po administration)
Time frame: up to 60 hours after drug administration
Number of patients with adverse events
Time frame: up to 20 days after final drug administration
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 8 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UH-AC 62 XX tablet and UH-AC 62 XX capsule in people with Healthy, run by Boehringer Ingelheim.
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 4 inclusion and 14 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Cmax (Maximum observed concentration of the analyte in plasma) (time frame: up to 60 hours after drug administration). 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 8 Jul 2014.