HealthyPhase 1NCT00387777
Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations
A Phase 1 study testing Patch with centrally acting analgesic and Transtec(R) PRO (buprenorphine) in people with Healthy, run by Grünenthal GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether Transtec(R) PRO 70 µg/h and a new buprenorphine patch formulation lead to same plasma levels of buprenorphine after multiple dose application. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Patch with centrally acting analgesic and Transtec(R) PRO (buprenorphine)
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Dec 2006
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male Caucasian subjects, aged 18 - 55 years
- BMI between 18 and 30 kg/m2 inclusive, with a lover limit of body weight of 50 kg
- Subjects must be in good health as determined by medical history, physical examination, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters
- Subjects giving written informed consent to participate within this trial
Who cannot join
- Resting pulse rate <= 45 or >= 100 beats/min
- Resting blood pressure:systolic blood pressure <= 90 and >= 160 mmHg, diastolic blood pressure <= 40 and >= 100 mmHg
- History or presence of orthostatic hypotension
- Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies, HCV antibodies
- Participation in another clinical trial in the last 30 days before starting this trial (i.e., first administration of IMP)
- Positive drug of abuse screening
Show all 27Show fewer
- Diseases or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- Marked repolarisation abnormality (e.g., suspicious or definite congenital long QT syndrome with QT/QTc>500msec or prolonged QTc, i.e.>450msec) or co-medication that is known to influence cardiac repolarisation substantially
- Bronchial asthma
- Definite or suspected history of drug allergy or hypersensitivity
- Subjects who have received any prescribed and non-prescribed systemic or topical medication like analgesics, NSAIDs (except standard dose of a NSAID once a week for the treatment of headache), hypnotics, sedatives, narcotics, neuroleptics or other medications that may lower the seizure threshold, MAO-inhibitors, serotonin-reuptake-inhibitors, tricyclic antidepressants, other centrally acting substances and substances which are known to interact with the drug metabolizing enzymes (e.g., inhibitors or inducers of CYP3A4 or CYP2D6) four weeks prior to the start of the trial (i.e, first administration of IMP). Each case has to be decided upon individually by the investigator after consultation with the sponsor
- Evidence of alcohol or drug abuse
- Not able to abstain from consumption of:
- Caffeine containing beverages or food (tea, coffee, cola, chocolate, etc.)
- Quinine containing beverages or food (bitter lemon, tonic water)
- Grapefruit juice (sweet, sour)
- Poppy seeds containing beverages or food
- Blood loss (> 100 mL) due to e.g., blood donation within 3 months before starting this trial (i.e., first administration of IMP)
- History of seizures or at risk (i.e. head trauma, epilepsy in family anamnesis, unclear loss of consciousness)
- Known or suspected of not being able to comply with the trial protocol
- Not able to communicate meaningfully with the investigator and staff
- Smoking of > 10 cigarettes/day or equivalent.
- Trial specific exclusion criteria:
- Subjects not able to abstain from strenuous exercise during the whole course of the trial
- Abnormality (e. g. scar, tattoo) or unhealthy skin at application site according to examination by the investigator
- Existing chronic skin disease or history of skin disease at the application site within the last 4 weeks
- Presence of one of the contraindications as detailed in the current Summary of Product Characteristics (SmPC).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple Dose Bioequivalence Trial Comparing a New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch.
The purpose of this study is to determine whether Transtec(R) PRO 70 µg/h and a new buprenorphine patch formulation lead to same plasma levels of buprenorphine after multiple dose application.
Read the detailed description
Main: To demonstrate the bioequivalence of the new buprenorphine transdermal patch T2rev formulation containing 13 mg buprenorphine (Test) as compared to Transtec(R) PRO 70 µg/h patch transdermal patch containing 40 mg buprenorphine as reference after multiple patch application. Pharmacokinetic target parameters are AUCss,Tau and Css,max.
Further: To assess the safety, tolerability, skin tolerability and adhesiveness of the patch applications. To evaluate the following further Pharmacokinetic parameters: Css,min, Css,ave, PTF, Swing, tss,max, and t1/2,z
- Conditions
- Healthy
- Being tested
- Patch with centrally acting analgesic, Transtec(R) PRO (buprenorphine)
- Keywords
- Buprenorphine, Transdermal patch, multidose, Centrally acting analgesic, Plasma level, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch with centrally acting analgesicDrug
Transtec(R) PRO (buprenorphine)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startOct 2006
- Study completionDec 2006
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
- 24 participants
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Baumann-Noss, MD, Principal investigator, IKP Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387777
- Sponsor's protocol ID
- 631766
- Other IDs
- 2006-003177-27, HP5303/10
- Status last verified
- Jan 2016
- First submitted
- 12 Oct 2006
- Last updated
- 11 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Dose Bioequivalence Trial Comparing a New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch.
- ClinicalTrials.gov ID
- NCT00387777
- Acronym / sponsor ID
- 631766
- Conditions
- Healthy
- Keywords
- Buprenorphine, Transdermal patch, multidose, Centrally acting analgesic, Plasma level, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Dec 2006
- First posted
- 13 Oct 2006 (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 determine whether Transtec(R) PRO 70 µg/h and a new buprenorphine patch formulation lead to same plasma levels of buprenorphine after multiple dose application.
Detailed description
Main: To demonstrate the bioequivalence of the new buprenorphine transdermal patch T2rev formulation containing 13 mg buprenorphine (Test) as compared to Transtec(R) PRO 70 µg/h patch transdermal patch containing 40 mg buprenorphine as reference after multiple patch application. Pharmacokinetic target parameters are AUCss,Tau and Css,max.
Further: To assess the safety, tolerability, skin tolerability and adhesiveness of the patch applications. To evaluate the following further Pharmacokinetic parameters: Css,min, Css,ave, PTF, Swing, tss,max, and t1/2,z
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male Caucasian subjects, aged 18 - 55 years
- BMI between 18 and 30 kg/m2 inclusive, with a lover limit of body weight of 50 kg
- Subjects must be in good health as determined by medical history, physical examination, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters
- Subjects giving written informed consent to participate within this trial
Key exclusion criteria (27 listed)
- Resting pulse rate <= 45 or >= 100 beats/min
- Resting blood pressure:systolic blood pressure <= 90 and >= 160 mmHg, diastolic blood pressure <= 40 and >= 100 mmHg
- History or presence of orthostatic hypotension
- Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies, HCV antibodies
- Participation in another clinical trial in the last 30 days before starting this trial (i.e., first administration of IMP)
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 |
|---|---|---|
| Patch with centrally acting analgesic | Drug | – |
| Transtec(R) PRO (buprenorphine) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
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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.
Dr. Baumann-Noss, MD principal investigator
IKP Mannheim
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 Patch with centrally acting analgesic and Transtec(R) PRO (buprenorphine) in people with Healthy, run by Grünenthal GmbH at 1 site in Germany.
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 27 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: stopped early, as of the sponsor's last update on 11 Jan 2016. 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 Germany. 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 was stopped early. Results are not available in the source record.
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.
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 11 Jan 2016.