The purpose of the study was to investigate the pharmacokinetics (i.e. the uptake, distribution and elimination from the body) of dermally applied buprenorphine during and after different application periods, i.e., a 96-hour and a 72-hour application of the Transtec (Registered Trademark) patch (release rate 35 micrograms per hour \[µg/hour\]). In the Transtec summary of product characteristics (prescribing information for the physician), the wearing time per patch is restricted to three days (72 hours) after which the patch has to be replaced. However, market experience has shown that the Transtec patches are sometimes worn for a period longer than three days, i.e. they sometimes happen to be only replaced every four days. There was currently no data available as how to evaluate this longer wearing period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Transdermal patch containing 20 mg buprenorphine in an active surface area of 25 squared centimeters. Buprenorphine release rate 35 µg/hour.
Institut für Klinische Pharmakologie Bobenheim
Grünstadt, Germany
Pharmacokinetic parameter: AUC48-72 for buprenorphine
Partial area under the plasma concentration-time curve (from 48 hours after application until 72 hours after application).
Time frame: From 48 hours to 72 hours
Pharmacokinetic parameter: AUC72-96 for buprenorphine
Partial area under the plasma concentration-time curve (from 72 hours after application until 96 hours after application).
Time frame: From 72 hours to 96 hours
Pharmacokinetic parameter: Cmax for buprenorphine
Maximum observed plasma concentration of the measured concentration-time profile. Blood samples will be taken for the determination of buprenorphine plasma concentrations at distinct time points: Before application to 144 hours after patch application. If the patch was applied for 96 hours, additional samples were taken at 156 and 168 hours after application. For the analysis of buprenorphine in human plasma, a validated liquid chromatography mass spectrometry (LC/MS/MS)-method will be used.
Time frame: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: tmax for buprenorphine
Time of maximum concentration, time after transdermal patch application at which Cmax occurs.
Time frame: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: AUC0-t for buprenorphine
Area under plasma concentration-time curve from application until the last sampling point (t) with a quantifiable concentration, calculated by the linear/log trapezoidal method, i.e., the linear trapezoidal rule is applied up to Cmax and then the log trapezoidal rule is applied for the remainder of the curve.
Time frame: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: t1/2z for buprenorphine
Apparent terminal elimination half-life.
Time frame: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: AUC0-inf for buprenorphine
Area under the plasma concentration-time curve extrapolated to infinity.
Time frame: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Incidence of treatment emergent adverse events
Number of adverse events and number of participants with adverse events.
Time frame: From patch application (Day 1) until Final check (Day 12)
Characteristics of treatment emergent adverse events
Adverse events with information on intensity, seriousness, relationship to the investigational product, outcome and action taken will be determined.
Time frame: From patch application (Day 1) until Final check (Day 12)
Onset and duration of treatment emergent adverse events
Adverse events with information on onset and duration to the investigational product will be determined.
Time frame: From patch application (Day 1) until Final check (Day 12)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.