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Opel Label Cross Over Study Pharmacokinetics (PK) Study in Healthy Volunteers Recieving Various Forms of Fentanyl

Information source: Depomed
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Fentanyl (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Depomed

Official(s) and/or principal investigator(s):
Head of R&D, Study Director, Affiliation: Depomed

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Pharmacokinetics area under the curve (AUC)

Detailed description: 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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 kg/m2. 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 significant. 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.

Locations and Contacts

Additional Information

Starting date: November 2014
Last updated: June 11, 2015

Page last updated: August 23, 2015

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