NCT02604992

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

November 12, 2015

Last Update Submit

January 18, 2016

Conditions

Healthy

Keywords

Comparative Bioavailability

Outcome Measures

Primary Outcomes (9)

  • Area under the curve from time 0 to the last measured concentration

    0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.

  • Area under the curve extrapolated to infinity

    0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.

  • Maximum plasma concentration

    0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.

  • Time to reach maximum plasma concentration

    0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.

  • Elimination rate constant

    0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.

  • The time prior to the first measurable (non-zero) concentration

    0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.

  • Elimination half-life

    0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.

  • Apparent oral clearance

    0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.

  • Volume of distribution

    0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.

Study Arms (6)

Group 1 (A,B,C)

EXPERIMENTAL

With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C.

Drug: Treatment ADrug: Treatment BDrug: Treatment C

Group 2 (B,C,A)

EXPERIMENTAL

With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A.

Drug: Treatment ADrug: Treatment BDrug: Treatment C

Group 3 (C,A,B)

EXPERIMENTAL

With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B.

Drug: Treatment ADrug: Treatment BDrug: Treatment C

Group 4 (C,B,A)

EXPERIMENTAL

With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A.

Drug: Treatment ADrug: Treatment BDrug: Treatment C

Group 5 (A,C,B)

EXPERIMENTAL

With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B.

Drug: Treatment ADrug: Treatment BDrug: Treatment C

Group 6 (B,A,C)

EXPERIMENTAL

With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C.

Drug: Treatment ADrug: Treatment BDrug: Treatment C

Interventions

Treatment ADRUG

Dronabinol oral solution, under fed conditions

Group 1 (A,B,C)Group 2 (B,C,A)Group 3 (C,A,B)Group 4 (C,B,A)Group 5 (A,C,B)Group 6 (B,A,C)
Treatment BDRUG

Dronabinol oral capsule, under fed conditions

Also known as: Marinol
Group 1 (A,B,C)Group 2 (B,C,A)Group 3 (C,A,B)Group 4 (C,B,A)Group 5 (A,C,B)Group 6 (B,A,C)
Treatment CDRUG

Dronabinol oral capsule, under fasted conditions

Also known as: Marinol
Group 1 (A,B,C)Group 2 (B,C,A)Group 3 (C,A,B)Group 4 (C,B,A)Group 5 (A,C,B)Group 6 (B,A,C)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Meets protocol-specified criteria for qualification
  • Fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the Investigator and study coordinator

You may not qualify if:

  • History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
  • Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
  • the safety or well-being of the participant or study staff
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  • the analysis of results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Neha Parikh

    INSYS Therapeutics Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 16, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

US(1)