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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00992095 |
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Date of registration:
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08/10/2009 |
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Primary sponsor: |
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Public title:
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Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
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Scientific title:
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A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Buprenorphine HCl (Sublingual) 8 mg Tablets With a Naltrexone Block Under Fasting Conditions |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00992095 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Fredrick A. Bieberdorf, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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CEDRA Clinical Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening.
Exclusion Criteria:
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs. History of allergic or adverse response
to buprenorphine hydrochloride or any comparable or similar product.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Opioid-Related Disorders
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Intervention(s)
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Drug: buprenorphine hydrochloride
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Primary Outcome(s)
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bioequivalence determined by statistical comparison Cmax
[Time Frame: 21 days]
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Secondary ID(s)
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BUPR-T8-PVFS-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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