PainPhase 1NCT02268422
Bioequivalence and Adhesion Comparison of Buprenorphine Patches
A Phase 1 study testing Buprenorphine in people with Pain, run by Mundipharma Research Limited at 2 sites in United Kingdom.
Trial summary
To compare a 2nd generation Buprenorphine Transdermal System (BTDS) patch with a marketed 1st generation BTDS patch to confirm that the two are bioequivalent (deliver the same amount of drug) and that they equally both stick to the skin over 7 days of continuous wear. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2014to Oct 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed consent.
- Healthy male or female subjects aged 18 to 55 inclusive.
- Female subjects of child bearing potential must be willing to use two highly effective methods of contraception throughout the study, one of which must include a barrier method. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device), true sexual abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the duration of the trial, and withdrawal are not acceptable methods of contraception) or vasectomised partner. Acceptable barrier methods are either their partner's use of a condom or the subject's use of an occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Female subjects who are postmenopausal (defined as spontaneous amenorrhoea for at least 1 year) or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). These subjects are not required to use any contraception.
- Male subjects who are willing to use contraception with their partners throughout the study and for 30 days after completion of the study and agree to inform the Investigator if their partner becomes pregnant during this time.
- Body weight ranging from 55 to 100 kg and a BMI ≥ 18.5 and ≤ 29.9.
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- Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
- Willing to eat all the food supplied throughout the study.
- The subject's primary care physician has confirmed within the last 12 months of the initial dosing date, that there is nothing in the subject's medical history that would preclude their enrolment into a clinical study.
- Will refrain from strenuous exercise during the entire study. They will not begin a new exercise program nor participate in any unusually strenuous physical exertion.
Who cannot join
- Female subjects who are pregnant or lactating.
- Any history of drug or alcohol abuse.
- Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of opioid or opioid antagonist-containing medication in the past 30 days.
- Any history of frequent nausea or vomiting regardless of aetiology.
- Any history of seizures or symptomatic head trauma.
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- Participation in a clinical drug study during the 90 days preceding the initial dose in this study, or participation in any other clinical drug study during this study.
- Any significant illness during the 4 weeks preceding entry into this study.
- A history of additional risk factors for Torsades de Pointes (e.g. heart failure, hypokalaemia, personal or family history of long QT syndrome, syncope, or family history of sudden death).
- Abnormal cardiac conditions including any of the following:
- QTcF interval greater than 450 msec at screening or at check-in before first dosing.
- Increase in QTcF of more than 60 msec above pre-dose values of each study period or QTcF > 500 msec at any time during the study.
- Use of medication within 5 times the half-life or minimum 14 days for prescription medication or 7 days for over-the-counter preparations (including vitamins, herbal and/or mineral supplements), whichever is longer, before the first dose of study treatment and during the study (with the exception of the continued use of Hormone Replacement Therapy (HRT) and contraceptives). Note: subjects taking oral contraceptives containing CYP3A4 inhibitors such as gestodene should be excluded as this may lead to elevated plasma concentrations.
- Refusal to abstain from caffeine or xanthine containing beverages and grapefruit juice within 48 hours before IMP administration until after the last study PK sample has been taken in each study period.
- Weekly alcohol intake exceeding the equivalent of 14 units/week for females and 21 units/week for males.
- Consumption of alcoholic beverages within 48 hours before IMP administration, and refusal to abstain from alcohol for the duration of the study confinement and for at least 48 hours after the last naltrexone dose in each study period.
- History of smoking within 45 days of IMP administration and refusal to abstain from smoking during the study.
- Blood or blood products donated within 90 days prior to IMP administration or any time during the study, except as required by this protocol.
- Positive results of urine drug screen, alcohol test, pregnancy test, HBsAg, Hepatitis C antibody, or HIV tests.
- Known sensitivity to buprenorphine, naltrexone, related compounds or any of the excipients or any contraindications as detailed in the Butrans Summary of Product Characteristics or Nemexin Summary of Product Characteristics.
- Clinically significant history of allergic reaction to wound dressings or elastoplast.
- Subjects with any dermatological disorder or tattoos at the proposed sites of patch application, or with a history of eczema/cutaneous atrophy.
- Subjects who will not allow hair to be removed at the proposed patch application sites which may prevent proper placement of the patch.
- Refusal to allow their primary care physician to be informed of participation in the study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Two-period, Randomised, Open-label, Crossover, Pharmacokinetic Study to Assess the Bioequivalence and Adhesion of Buprenorphine Transdermal System Second Generation Patch Compared With First Generation Patch, in Healthy Volunteers
To compare a 2nd generation Buprenorphine Transdermal System (BTDS) patch with a marketed 1st generation BTDS patch to confirm that the two are bioequivalent (deliver the same amount of drug) and that they equally both stick to the skin over 7 days of continuous wear.
Read the detailed description
The objective is to compare a 2nd generation BTDS patch 20 µg/h to the 1st generation patch to confirm bioequivalence. Determination will be via measurement of drug concentrations in the blood at serial collection time points pre-dose until 288 hours post-patch application. Approximately 100 healthy male and female volunteers will receive both BTDS patches across two study periods with a 14-day wash-out between applications.
Each patch will be worn for 7 consecutive days and the study will also review the adhesion of each patch to the skin of the subjects. The overall safety and tolerability of both patches will be assessed.
- Conditions
- Pain
- Being tested
- Buprenorphine
- Keywords
- Healthy volunteer, crossover, open-label, randomised, bioequivalence, pharmacokinetic study
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
7 day patch
| Study group | Role | What they receive |
|---|---|---|
| 7 day patch | Experimental | Buprenorphine transdermal system (BTDS) 2nd generation Receives: Drug: Buprenorphine |
| 7 Day Patch | Active comparator | 1st Generation BTDS: Butrans Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Pharmacokinetics parameters AUC and Cmax assessments
Measured: Up to 288 hours
Patch adhesion
Patch site adhesion
Measured: 168 hours
Secondary outcomes (2)
Residual Buprenorphine content following 7 days of wear
Determination of residual Buprenorphine content remaining in both BTDS patches following removal
Measured: 168 hours
Measure of Safety and tolerability
Adverse event assessment from all subjects over the entire study
Measured: From screening to 40 days after patch application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268422
- Sponsor's protocol ID
- BUP1507
- Other IDs
- 2014-002116-17, 2014
- Status last verified
- Feb 2016
- First submitted
- 9 Oct 2014
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-period, Randomised, Open-label, Crossover, Pharmacokinetic Study to Assess the Bioequivalence and Adhesion of Buprenorphine Transdermal System Second Generation Patch Compared With First Generation Patch, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02268422
- Acronym / sponsor ID
- BUP1507
- Conditions
- Pain
- Keywords
- Healthy volunteer, crossover, open-label, randomised, bioequivalence, pharmacokinetic study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Oct 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.
To compare a 2nd generation Buprenorphine Transdermal System (BTDS) patch with a marketed 1st generation BTDS patch to confirm that the two are bioequivalent (deliver the same amount of drug) and that they equally both stick to the skin over 7 days of continuous wear.
Detailed description
The objective is to compare a 2nd generation BTDS patch 20 µg/h to the 1st generation patch to confirm bioequivalence. Determination will be via measurement of drug concentrations in the blood at serial collection time points pre-dose until 288 hours post-patch application. Approximately 100 healthy male and female volunteers will receive both BTDS patches across two study periods with a 14-day wash-out between applications.
Each patch will be worn for 7 consecutive days and the study will also review the adhesion of each patch to the skin of the subjects. The overall safety and tolerability of both patches will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 day patch | Experimental | Drug: BuprenorphineBuprenorphine transdermal system (BTDS) 2nd generation |
| 7 Day Patch | Active comparator | Drug: Buprenorphine1st Generation BTDS: Butrans |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Provide written informed consent.
- Healthy male or female subjects aged 18 to 55 inclusive.
- Female subjects of child bearing potential must be willing to use two highly effective methods of contraception throughout the study, one of which must include a barrier method. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device), true sexual abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the duration of the trial, and withdrawal are not acceptable methods of contraception) or vasectomised partner. Acceptable barrier methods are either their partner's use of a condom or the subject's use of an occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Female subjects who are postmenopausal (defined as spontaneous amenorrhoea for at least 1 year) or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). These subjects are not required to use any contraception.
- Male subjects who are willing to use contraception with their partners throughout the study and for 30 days after completion of the study and agree to inform the Investigator if their partner becomes pregnant during this time.
Key exclusion criteria (24 listed)
- Female subjects who are pregnant or lactating.
- Any history of drug or alcohol abuse.
- Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of opioid or opioid antagonist-containing medication in the past 30 days.
- Any history of frequent nausea or vomiting regardless of aetiology.
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 |
|---|---|---|
| Buprenorphine7 day patch | Drug | 7 Day Patch, 7 day patch |
Primary outcome
Bioequivalence
Time frame: Up to 288 hours
Pharmacokinetics parameters AUC and Cmax assessments
Patch adhesion
Time frame: 168 hours
Patch site adhesion
2 secondary outcomes
Residual Buprenorphine content following 7 days of wear
Time frame: 168 hours
Measure of Safety and tolerability
Time frame: From screening to 40 days after patch application
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 9 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Buprenorphine in people with Pain, run by Mundipharma Research Limited at 2 sites in United Kingdom.
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 10 inclusion and 24 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 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Bioequivalence (time frame: Up to 288 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 9 Feb 2016.