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Buprenorphine Transdermal Patches Pharmacokinetic Study

Unknown statusPhase 1NCT03975010
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This is an open-label, randomised, single-dose, 3 arms study design.

Study details

Official title
An Open-label, Randomized, Single-dose, Parallel-group Study to Investigate the PK Profile of Single Dose Buprenorphine Transdermal Patch 20 mg Applied for 3 Days, 40 mg for 3 Days and 40 mg for 4 Days in Chinese Subjects With Chronic Pain
Conditions
Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
Start date
2019-05-13
Primary completion
2020-03-31
Sex
All
Age range
from 18 Years to 55 Years
Results posted
No results posted in this snapshot
Countries
China
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Chinese male or female subjects with chronic pain (regardless of the aetiology, cancer-pain excluded), aged 18-55 years (both inclusive). * The average pain over the last 24 hours should attain ≤ 3 assessed with Numeric Rating Scales (NRS) refer to section 19.5. The pain condition has been lasting for at least 1 month and stable for 7 days prior to entering into the screening and is expected to be stable during the study duration. * Patients on stable permissible non-opioid analgesics, who in the opinion of the investigator are unlikely to require a change in treatment during the study. * Karnofsky score of Performance Status ≥ 70. * Body mass index (BMI) of 19 to 28 kg/m2 (both inclusive); and a total body weight ≥ 50 kg. * Normal dietary habits (e.g. not vegetarian nor vegan) and willing to only take the food supplied during the period of hospitalization. * Subjects who are able to read, understand and sign written informed consent prior to study participation and are willing to follow the protocol requirements. * Female subjects of child bearing potential (less than 1 year post-menopausal) must have a negative urine pregnancy test prior to first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of birth control throughout the study such as sterilisation, implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Male subjects (surgical history of bilateral vasectomy excluded) with a partner of child bearing potential must be willing to use adequate and highly effective methods of birth control throughout the study. Exclusion Criteria: * Unstable condition of the primary disease of chronic pain, which, in the opinion of the investigator, would complicate the subject's participation in the study (e.g. require initiation of new medication). * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies). * History of seizures or at risk (i.e. head trauma, epilepsy in family, anamnesis, unclear loss of consciousness). * Any history of frequent nausea or emesis regardless of aetiology. * Malignancy or a history of malignancy. * History of orthostatic hypotension. * Subjects who have any medical or surgical conditions that might interfere with transdermal absorption, distribution, me…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03975010