Bioequivalence and Adhesion Comparison of Buprenorphine Patches

NCT02268422 | Completed Phase 1

• 2 other identifiers: BUP15072014-002116-17
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain

Keywords

Healthy volunteer; crossover; open-label; randomised; bioequivalence; pharmacokinetic study

Outcome Measures

Primary Outcomes (2)

• Bioequivalence

  Pharmacokinetics parameters AUC and Cmax assessments

  Up to 288 hours

• Patch adhesion

  Patch site adhesion

  168 hours

Secondary Outcomes (2)

• Residual Buprenorphine content following 7 days of wear

  168 hours

• Measure of Safety and tolerability

  From screening to 40 days after patch application

Study Arms (2)

7 day patch

EXPERIMENTAL

Buprenorphine transdermal system (BTDS) 2nd generation

Drug: Buprenorphine

7 Day Patch

ACTIVE COMPARATOR

1st Generation BTDS: Butrans

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

7 day patch

7 Day Patch; 7 day patch

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (2)

Unknown Facility

Croydon, United Kingdom

Location

Unknown Facility

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2015
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

GB (2)