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

This study has been completed.
Information provided by (Responsible Party):
Nanotherapeutics, Inc. Identifier:
First received: December 13, 2010
Last updated: April 13, 2015
Last verified: April 2015
Phase 1 study to determine the pharmacokinetic profile of NanoBUP Capsules to Suboxone.

Condition Intervention
Drug: Buprenorphine HCl/Naloxone HCl

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 ]

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

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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy normal volunteers

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.
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Please refer to this study by its identifier: NCT01260675

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

Responsible Party: Nanotherapeutics, Inc. Identifier: NCT01260675     History of Changes
Other Study ID Numbers: 2009-BUP-NT/002
Study First Received: December 13, 2010
Last Updated: April 13, 2015

Keywords provided by Nanotherapeutics, Inc.:
phase 1 study

Additional relevant MeSH terms:
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on May 25, 2017