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Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions

NCT00992095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-01-23

No results posted yet for this study

Summary

The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted conditions.

Conditions

  • Opioid-Related Disorders

Interventions

DRUG

buprenorphine hydrochloride

single dose 8 mg sublingual tablet

Sponsors & Collaborators

  • Roxane Laboratories

    lead INDUSTRY

Principal Investigators

  • Fredrick A. Bieberdorf, M.D. · CEDRA Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00992095 on ClinicalTrials.gov