HealthyPhase 1NCT00460785
Bioequivalence Trial of a New Opioid Combination Compared to Reference
A Phase 1 study testing Opioid in people with Healthy, run by Grünenthal GmbH.
Trial summary
The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Opioid
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Mar 2007
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Standard Phase I
- Cyp 2D6 extensive metabolizers
Who cannot join
- Standard Phase I
- Contraindications of current reference tablet SmPC
About this study
Official title: Phase 1 Single Center Trial to Demonstrate the Bioequivalence of a New Combination Analgesic Formulation as Compared to an Equimolar Marketed Formulation
The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference
- Conditions
- Healthy
- Being tested
- Opioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpioidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.
Secondary outcomes (1)
Descriptive, e. g. safety/tolerability of Test comparable to Reference
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startFeb 2007
- Study completionMar 2007
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
- 32 participants
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wolfgang Timmer, Dr., Principal investigator, CRS Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460785
- Sponsor's protocol ID
- 544506
- Status last verified
- Mar 2007
- First submitted
- 28 Mar 2007
- Last updated
- 6 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Single Center Trial to Demonstrate the Bioequivalence of a New Combination Analgesic Formulation as Compared to an Equimolar Marketed Formulation
- ClinicalTrials.gov ID
- NCT00460785
- Acronym / sponsor ID
- 544506
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Apr 2007 (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.
The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Standard Phase I
- Cyp 2D6 extensive metabolizers
Key exclusion criteria (2 listed)
- Standard Phase I
- Contraindications of current reference tablet SmPC
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 |
|---|---|---|
| Opioid | Drug | – |
Primary outcome
Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.
1 secondary outcome
Descriptive, e. g. safety/tolerability of Test comparable to Reference
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 6 Jul 2007.
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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.
Wolfgang Timmer, Dr. principal investigator
CRS Mannheim
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Opioid in people with Healthy, run by Grünenthal GmbH.
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 2 inclusion and 2 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 6 Jul 2007. 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?
Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax.. 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 6 Jul 2007.