MedTrace Logo

Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers

NCT02604992 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-01-20

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (RLD) administered to participants under fed and fasted conditions.

The secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.

Conditions

  • Healthy

Interventions

DRUG

Treatment A

Dronabinol oral solution, under fed conditions

DRUG

Treatment B

Dronabinol oral capsule, under fed conditions

DRUG

Treatment C

Dronabinol oral capsule, under fasted conditions

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Neha Parikh · INSYS Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02604992 on ClinicalTrials.gov