Phase 1
Completed N=70
Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods
Healthy
Source: ClinicalTrials.gov NCT01259102 ↗
Enrolled (actual)
70
Serious AEs
1.4%
Results posted
Feb 2011
Primary outcomePrimary: Period 1: AUC0-3d — 8680; 7651; 6465; 12258 pg/mL*h
Summary
The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Period 1: AUC0-3d |
8680; 7651; 6465; 12258; 8890 | — |
| PRIMARY Period 2: AUC0-3d. |
12316; 14733; 13571; 12931; 9056 | — |
| PRIMARY Period 1: Cmax0-3d |
183; 193; 151; 241; 185 | — |
| PRIMARY Period 2: Cmax0-3d |
216; 300; 262; 278; 182 | — |
| SECONDARY Period 1: AUC0-7d. |
21946; 20541; 14707; 27040; 22086 | — |
| SECONDARY Period 2: AUC0-7d |
25126; 27543; 26174; 27123; 21790 | — |
| SECONDARY Period 1: Cmax0-7 |
188; 206; 160; 245; 192 | — |
| SECONDARY Period 2: Cmax0-7d |
216; 300; 262; 278; 202 | — |
| SECONDARY Period 1: Tmax0-7d. |
74; 86; 78; 55; 76 | — |
| SECONDARY Period 2: Tmax0-7d. |
42; 38; 36; 46; 63 | — |
Eligibility Criteria
Inclusion Criteria Include:
- Males and females 18 to 45 years of age, inclusive.
- Weight of 60 to 100 kilograms (kg) [132-220 pounds (lb)] and within 15% of optimum for height and body frame.
- In good health, evidenced by a lack of significantly abnormal findings on medical history, physical examination, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
- Willing to discontinue and abstain from any medications, including vitamins or mineral supplements, throughout the study.
- Willing to follow dietary restrictions, including abstention from caffeine and xanthine-containing beverages for the duration of the study.
- Did not smoke or chew tobacco for at least 45 days prior to administration of study drugs, and agree not to use tobacco products during the study
Exclusion Criteria Include:
- A history of hypersensitivity to opioid or psychotropic drugs.
- A history of recurrent seizures or syncope.
- Any medical or surgical conditions which might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
- Any other significant active medical illness such as: history or presence of liver disease or liver injury that is indicated by an abnormal liver function profile such as aspartate transaminase (AST), alanine transaminase (ALT), or serum bilirubin; history or presence of impaired renal function that is indicated by abnormal creatinine or blood urea nitrogen (BUN) values or abnormal urinary constituents (eg, albuminuria); history of neutropenia (absolute neutrophil count [ANC] <1000/mm3 or thrombocytopenia (platelet <150,000/mm3).
- Positive results of urine drug screen or urine cotinine (consistent with active smoking).
- A history of substance or alcohol abuse within the past 5 years.
- Females who are nursing.
- Females who are pregnant as confirmed by a positive serum human chorionic gonadotropin (bHCG) test.
Other protocol-specific exclusion/inclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01259102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.