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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:April 2009
End Date:May 2009

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A Single-Dose, 1-Period, 1-Treatment Pilot Study of an Investigational Capsule Formulation of 2 mg/.05 mg Buprenorphine/Naloxone Under Fasting Conditions

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

NIDA Contract No. HHSN271200577414C


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.
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