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A Single-Dose Study of an Investigational Capsule Formulation of 2 mg/0.5 mg Buprenorphine/Naloxone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00880841
First Posted: April 14, 2009
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
NanoSHIFT LLC
  Purpose

A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg Buprenorphine/Naloxone.

NIDA Contract No. HHSN271200577414C


Condition Intervention
Healthy Drug: Buprenorphine / Naloxone

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: A Single-Dose, 1-Period, 1-Treatment Pilot Study of an Investigational Capsule Formulation of 2 mg/.05 mg Buprenorphine/Naloxone Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by NanoSHIFT LLC:

Primary Outcome Measures:
  • pharmacokinetic profile of an investigational formulation of buprenorphine HCl/naloxone HCl 2mg/0.5mg oral capsules [ Time Frame: pk blood draws over a 72 hour period ]

Enrollment: 6
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
no treatment
phase 1a study for healthy normals
Drug: Buprenorphine / Naloxone
oral formulation of buprenorphine / naloxone
Other Name: NanoBUP

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
healthy normals between the ages of 18 and 55 (inclusive)
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.
  • Has 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.
  • Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
  • Has donated blood or plasma within 30 days prior to the first dose of study medication.
  • Has participated in another clinical trial within 30 days prior to the first dose of study medication.
  • Has used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
  • Has 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.
  • Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
  • Has history of substance abuse or dependence (including alcohol, opioids, or intravenous drug abuse)
  • Is a female with a positive pregnancy test result.
  • Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
  • Has 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.
  • Has had a positive test for, or has been treated for hepatitis B, hepatitis C, or HIV.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880841


Locations
United States, Texas
CEDRA Clinical Research
Austin, Texas, United States, 78759
Sponsors and Collaborators
NanoSHIFT LLC
Investigators
Principal Investigator: Mark Leibowitz, MD CEDRA Clinical Research
  More Information

Responsible Party: NanoSHIFT LLC
ClinicalTrials.gov Identifier: NCT00880841     History of Changes
Other Study ID Numbers: 20-A93-AU
First Submitted: April 13, 2009
First Posted: April 14, 2009
Last Update Posted: June 23, 2017
Last Verified: June 2017

Keywords provided by NanoSHIFT LLC:
healthy normals, phase 1
phase 1a study for healthy normals

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