Open Label Crossover Study Pharmacokinetics (PK) Study in Healthy Volunteers Receiving Various Forms of Fentanyl

Not Recruiting

Trial ID: NCT02470390


A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and bioavailability study in healthy volunteers.

Official Title

An Open-Label Single-Dose Crossover Study Comparing the Plasma and Cerebrospinal Fluid Pharmacokinetics and Bioavailability of Fentanyl Delivered Intranasally Versus Sublingually Versus Intravenously in Healthy Volunteers

Stanford Investigator(s)

Peter Schmidt
Peter Schmidt

Clinical Assistant Professor, Anesthesiology, Perioperative and Pain Medicine


Inclusion Criteria:

   - Normal healthy male or female between the ages of 18 to 65 years. Never smokers or
   Non-smokers (cessation of smoking ≥ 6 months ago). Body Mass Index (BMI =
   weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 32.0

No clinically meaningful findings in the physical examination, oral and nasal examination
and 12-lead electrocardiogram.

Negative for drugs of abuse, alcohol, and nicotine. Negative for hepatitis A, B, and C and
Human Immunodeficiency Virus (HIV). No clinical laboratory values outside of the acceptable
range, unless, in the opinion of the Principal Investigator, they are deemed not clinically

Exclusion Criteria:

   - Subject has a known history of allergic reaction, hypersensitivity, or clinically
   significant intolerance to opioids, fentanyl or components of the study drugs.

   2. Subjects with a high potential for opioid addiction (personal or family history).

   3. Subject is lactating or considered at risk of pregnancy. 4. Subject has impaired
   liver function (e.g., alanine aminotransferase [ALT] ≥ 3 times the upper limit of
   normal [ULN] or bilirubin ≥ 3 times ULN), known active hepatic disease (e.g.,
   hepatitis), or evidence of clinically significant liver disease or other condition
   affecting the liver that may suggest the potential for an increased susceptibility to
   hepatic toxicity with oral diclofenac exposure.

   5. Subject has any history of renal disease that, in the opinion of the investigator,
   would contraindicate study participation; or subject has significantly impaired renal
   function as evidenced by an estimated GFR of ≤60 ml/min/1.73m2.

   6. Subject has a history or evidence of significant nasal pathology, including polyps
   or nasal obstructions.


drug: Fentanyl

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305