Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01157169
First received: July 2, 2010
Last updated: November 22, 2010
Last verified: November 2010
  Purpose

The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc. to an equivalent oral dose of the commercially available reference product, Subutex® manufactured by Reckitt Benckiser, following and overnight fast of at least 10 hours.


Condition Intervention Phase
Healthy
Drug: Buprenorphine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax of Buprenorphine. [ Time Frame: Blood samples collected over a 144 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).

  • AUC0-t for Buprenorphine. [ Time Frame: Blood samples collected over a 144 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).

  • AUC0-inf for Buprenorphine. [ Time Frame: Blood samples collected over a 144 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity).


Secondary Outcome Measures:
  • Cmax for Norbuprenorphine. [ Time Frame: Blood samples collected over a 144 hour period. ] [ Designated as safety issue: No ]
    Informational comparison of Cmax (maximum observed concentration of drug substance in plasma) values for the metabolite Norbuprenorphine.

  • AUC0-t for Norbuprenorphine. [ Time Frame: Blood samples collected over a 144 hour period. ] [ Designated as safety issue: No ]
    Informational comparison of AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) values for the metabolite Norbuprenorphine.

  • AUC0-inf for Norbuprenorphine. [ Time Frame: Blood samples collected over a 144 hour period. ] [ Designated as safety issue: No ]
    Informational comparison of AUC0-inf (area under the concentration-time curve from time zero to infinity) values for the metabolite Norbuprenorphine.


Enrollment: 40
Study Start Date: August 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Test Product
Buprenorphine 8 mg Sublingual Tablets
Drug: Buprenorphine
8 mg Sublingual Tablets
Active Comparator: Reference Listed Drug
Subutex® 8 mg Sublingual Tablets
Drug: Buprenorphine
8 mg Sublingual Tablets
Other Name: Subutex®

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must be a male or non-pregnant, non-breastfeeding female.
  • Subject must be between 18 and 45 years of age (inclusive).
  • Subject's Body Mass Index (BMI) must be between 18 and 30 (inclusive), and subject must weigh a minimum of 50 kg (110 lbs).
  • Female subjects must agree to utilize one of the following forms of contraception from screening through 4 weeks after completion of the study. Approved forms of contraception are abstinence, double barrier, IUD in place at least 30 days prior to study drug administration, vasectomized partner, surgically sterile for at least 6 months, or at least 2 years postmenopausal.
  • Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion 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 all scheduled outpatient visits.

Exclusion Criteria:

  • History or presence of any clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, 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.
  • History or presence of pancreatitis, bowel obstruction, glaucoma, enlargement of the prostate, adrenal disease, hyperthyroidism, or gallbladder disease. Subjects with a history of cholecystectomy for the treatment of gallbladder disease will be excluded.
  • Females taking any oral contraceptives including estrogen and progestin combined pills, progestin-only pills, patch, or vaginal ring within 28 days prior to the first dose of study medication; using injectable contraceptives within 6 months of first dose; or who have ever had progestational hormone implants.
  • Females taking hormone replacement therapy within 60 days prior to the first dose of study medication.
  • 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, naltrexone, or any comparable or similar product.
  • 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 cough and cold preparations, vitamins, and herbal supplements, within 7 days prior to the first dose of study medication.
  • Has used any prescription medication within 14 days prior to the first dose of study medication.
  • Has consumed beverages or food containing alcohol, caffeine/xanthine, or poppy seeds from 48 hours prior to the first dose of study medication or has consumed beverages or foods containing grapefruit from 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 a history of treatment for substance abuse (including alcohol) in the past 5 years.
  • Is a female with a positive pregnancy test result.
  • Has any piercing of the tongue or has a lip piercing within 30 days prior to the first dose of study medication.
  • Has a positive urine screen for drugs of abuse.
  • Has a positive urine alcohol test or ethanol breath test.
  • Has 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: NCT01157169

Locations
United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Frederick A Bieberdorf, M.D., CPI CEDRA Clinical Research, LLC
  More Information

No publications provided

Responsible Party: TEVA Pharmaceuticals, USA
ClinicalTrials.gov Identifier: NCT01157169     History of Changes
Other Study ID Numbers: 20-A63-AU
Study First Received: July 2, 2010
Results First Received: August 18, 2010
Last Updated: November 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy

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

ClinicalTrials.gov processed this record on August 21, 2014