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Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

NCT01380457 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2011-06-27

No results posted yet for this study

Summary

The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg capsules verses Marinol.

Conditions

  • To Determine Bioequivalence Under Fasting Conditions

Interventions

DRUG

Dronabinol

Capsules, 10 mg, single dose, fasting conditions

DRUG

Marinol

Capsules, 10 mg, single-dose, fasting conditions

Sponsors & Collaborators

  • BASi Clinical Research Unit

    collaborator UNKNOWN

  • Par Pharmaceutical, Inc.

    lead INDUSTRY

Principal Investigators

  • Dilip K Guha-Ray, M.D. · BASi Baltimore Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-04-30
Completion
2006-04-30

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 NCT01380457 on ClinicalTrials.gov