Study to Assess the PK Profile of NanoBUP Capsules Relative to Suboxone

This study has been completed.
Sponsor:
Information provided by:
Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01260675
First received: December 13, 2010
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

Phase 1 study to determine the pharmacokinetic profile of NanoBUP Capsules to Suboxone.


Condition
Healthy Volunteers

Study Type: Observational
Official Title: A Study to Assess the Pharmacokinetic Profile of an Investigational Formulation of Buprenorphine HCl/Naloxone HCl 8mg/2mg Capsules Relative to the Pharmacokinetic Profile of Suboxone® (Buprenorphine HCl/Naloxone HCl 8mg/2mg Sublingual Tablets).

Resource links provided by NLM:


Further study details as provided by Nanotherapeutics, Inc.:

Primary Outcome Measures:
  • pharmacokinetic profile of NanoBUP Capsules relative to Suboxone [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: December 2010
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
NanoBUP Capsules
Investigational Formulation of Buprenorphine HCl/Naloxone HCl 8 mg/2 mg oral capsules
Suboxone Sublingual Tablets
Buprenorphine HCl/Naloxone HCl 8 mg/2 mg sublingual tablets

Detailed Description:

The pharmacokinetics of an orally administered investigational buprenorphine hydrochloride/naloxone hydrochloride 2 mg/0.5 mg capsule formulation will be studied. This is a single-dose, two period, two treatment, crossover comparative bioavailability study under fasting conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy normal volunteers

Criteria

Inclusion Criteria:

  • Subject must be a male or non-pregnant, non-breastfeeding female.
  • Subject must be between 18 and 55 years of age (inclusive).
  • Subject's Body Mass Index (BMI) must be between 18 and 30 kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110 lbs).
  • Female subjects - not surgically sterile for at least 6 months or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, vaginal, or injection) in use at least 3 consecutive months prior to the first dose of study medication, double barrier (condom with spermicide; diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
  • Subject must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures.
  • Subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for any outpatient visits

Exclusion Criteria:

  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, metabolic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
  • A clinically significant abnormal finding on the physical exam, medical history, ECG, or clinical laboratory results at screening.
  • History or presence of allergic or adverse response to buprenorphine, naloxone, naltrexone, opioids, or any comparable or similar products.
  • Been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
  • Donated blood or plasma within 30 days prior to the first dose of study medication.
  • Participated in another clinical trial within 30 days prior to the first dose of study medication.
  • Used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
  • Used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
  • Has been treated with any known enzyme altering drugs, such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
  • Smoked or used tobacco products within 60 days prior to the first dose of study medication.
  • History of substance abuse or dependence (including alcohol, opioids, or intravenous drug abuse)
  • Is a female with a positive pregnancy test result.
  • A positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
  • A positive urine alcohol test at screening or a positive ethanol breath test at check-in for the study period or has consumed alcohol within 48 hours prior to screening or check-in for the study period.
  • Had a positive test for, or has been treated for hepatitis B, hepatitis C, or HIV.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260675

Locations
United States, Texas
Worldwide Clinical Trials
San Antonia, Texas, United States, 78217
Sponsors and Collaborators
Nanotherapeutics, Inc.
Investigators
Principal Investigator: Michael Natalino, MD Worldwide Clinical Trials
  More Information

No publications provided

Responsible Party: John Abernethy, MD, Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01260675     History of Changes
Other Study ID Numbers: 2009-BUP-NT/002
Study First Received: December 13, 2010
Last Updated: February 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Nanotherapeutics, Inc.:
phase 1 study of healthy normals

Additional relevant MeSH terms:
Buprenorphine
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 22, 2014