Transdermal Patch CVD 2000: The Effect of Heat on Fentanyl Release From Fentanyl TDSs in Healthy Adults

NCT02486016 | Completed Phase 4 Results

• 1 other identifier: HP-00059884
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan) fentanyl (transdermal delivery system)TDSs in healthy adults.

Conditions

Peer Review, Research

Keywords

Bioequivalence; Therapeutic Equivalency

Outcome Measures

Primary Outcomes (1)

• Partial Area Under the Curve (AUC) Attained With Early and Late Heat in Each of the Three Fentanyl TDSs (Reference and Generic)

  Partial area under the flux-time curve of fentanyl calculated from 11 to 14 h for Early Heat and 18 to 21 h for Late Heat study designs Blood samples obtained at 15 min prior to patch application \[baseline\], and at 1:00, 10:00, 10:55, 11:05, 11:15, 11:25, 11:35, 11:45, 12:00, 13:00, 14:00, 16:00, 17:00, 17:55, 18:05, 18:15, 18:25, 18:35, 18:45, 19:00, 20:00, 21:00, and 22:00 h post-patch application

  six procedure days for each participant

Study Arms (3)

Duragesic Reference Fentanyl TDS

EXPERIMENTAL

Each volunteer participates in two procedure days using the Duragesic reference (RLD) fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively.

Drug: Duragesic reference fentanyl TDS

Apotex Generic Fentanyl TDS

ACTIVE COMPARATOR

Each volunteer participates in two procedure days using the Apotex generic fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively.

Drug: Apotex generic fentanyl TDS

Mylan Generic Fentanyl TDS

ACTIVE COMPARATOR

Each volunteer participates in two procedure days using the Mylan generic fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively.

Drug: Mylan generic fentanyl TDS

Interventions

Duragesic reference fentanyl TDS DRUG

25 µg/hour

Also known as: Brand name fentanyl TDS

Duragesic Reference Fentanyl TDS

Apotex generic fentanyl TDS DRUG

25 µg/hour

Also known as: Generic fentanyl TDS

Apotex Generic Fentanyl TDS

Mylan generic fentanyl TDS DRUG

25 µg/hour

Also known as: Generic fentanyl TDS

Mylan Generic Fentanyl TDS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Men or non-pregnant women of any ethnic background between the age of 18 and 45 years old.
• \. Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 2 months and are not currently using tobacco products.
• \. Provide written informed consent before initiation of any study procedures.
• \. Available for follow-up for the planned duration of the study.
• \. Able to communicate well with the investigators.
• \. Able to adhere to the study protocol schedule.
• \. Subjects who are within their ideal body weight (BMI\>17 and ≤ 28).
• \. Demonstrate comprehension of the protocol procedures and knowledge of study by passing (\>70% correct responses) a written examination containing 20 multiple choice and true false questions covering all aspects of the study including the purpose, procedures, risks and benefits.
• \. Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination, and medication history.
• \. Negative urine drug screening test.
• \. Have a normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (55-100 bpm).
• \. Have normal screening laboratories for WBC, Hgb, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT, AST and total bilirubin.
• \. Have normal screening laboratories for urine protein and urine glucose.
• \. Female subjects must be of non-childbearing potential (as defined as surgically sterile \[i.e. history of hysterectomy or tubal ligation\] or postmenopausal for more than 1 year), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of each procedure, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner.
• \. Agrees not to participate in another clinical study during the study period.

You may not qualify if:

• \. Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or on the morning of any procedure day.
• \. Smokers (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes).
• \. Participation in any ongoing investigational drug trial or clinical drug trial.
• \. Abnormal Vital signs, defined as:
• Hypertension (systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg) at rest on 2 separate days)
• Heart rate \<55 at rest on 2 separate days
• Respiratory rate \>20
• \. Temperature \> 38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of application of the fentanyl TDS.
• \. History of chronic obstructive pulmonary disease.
• \. Active positive Hepatitis B, C, and HIV serologies.
• \. Positive urine drug screening test.
• \. Use of any prescription medication during the period 0 to 30 days or over-the counter medication (vitamin, herbal supplements and birth control medications not included) during the period 0 to 3 days before entry to the study.
• \. Donation or loss of greater than one pint of blood within 60 days of entry to the study.
• \. Any prior serious adverse reaction or hypersensitivity to fentanyl, naltrexone or naloxone or any of the inactive ingredients in the TDS (alcohol, ethylene vinyl acetate-copolymer membrane and hydroxyethyl cellulose, polyester, silicone adhesive, isopropyl myristate, octyldodecanol, polybutene, polyisobutene, dimethicone NF, or polyolefin).
• \. Have a diagnosis of schizophrenia or other major psychiatric diagnosis or mental illness (e.g. major depression).

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

University of Maryland, Baltimore Center for Vaccine Development

Baltimore, Maryland, 21201, United States

Location

Results Point of Contact

• Title: Dr. Audra Stinchomb (PI)
• Organization: University of Maryland, Baltimore School of Pharmacy

astinchc@rx.umaryland.edu

410-706-2646

Study Officials

• Audra Stinchcomb, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: June 30, 2015
• Study Start: July 9, 2015
• Primary Completion: August 8, 2017
• Study Completion: August 9, 2017
• Last Updated: March 23, 2020
• Results First Posted: September 10, 2019

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)