Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers

An Open-Label, Randomized, Single-Dose, Two-Period, Two-Way Crossover Comparative Bioavailability Study of Dronabinol Oral Solution, 4.25 mg to Marinol Capsule, 5 mg in Healthy Volunteers Under Fed Conditions

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78217
      • Worldwide Clinical Trials Early Phase Services, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (A,B,C); With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C.	Drug: Treatment A; Dronabinol oral solution, under fed conditions; Drug: Treatment B; Dronabinol oral capsule, under fed conditions; Other Names: Marinol; Drug: Treatment C; Dronabinol oral capsule, under fasted conditions; Other Names: Marinol
Experimental: Group 2 (B,C,A); With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A.	Drug: Treatment A; Dronabinol oral solution, under fed conditions; Drug: Treatment B; Dronabinol oral capsule, under fed conditions; Other Names: Marinol; Drug: Treatment C; Dronabinol oral capsule, under fasted conditions; Other Names: Marinol
Experimental: Group 3 (C,A,B); With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B.	Drug: Treatment A; Dronabinol oral solution, under fed conditions; Drug: Treatment B; Dronabinol oral capsule, under fed conditions; Other Names: Marinol; Drug: Treatment C; Dronabinol oral capsule, under fasted conditions; Other Names: Marinol
Experimental: Group 4 (C,B,A); With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A.	Drug: Treatment A; Dronabinol oral solution, under fed conditions; Drug: Treatment B; Dronabinol oral capsule, under fed conditions; Other Names: Marinol; Drug: Treatment C; Dronabinol oral capsule, under fasted conditions; Other Names: Marinol
Experimental: Group 5 (A,C,B); With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B.	Drug: Treatment A; Dronabinol oral solution, under fed conditions; Drug: Treatment B; Dronabinol oral capsule, under fed conditions; Other Names: Marinol; Drug: Treatment C; Dronabinol oral capsule, under fasted conditions; Other Names: Marinol
Experimental: Group 6 (B,A,C); With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C.	Drug: Treatment A; Dronabinol oral solution, under fed conditions; Drug: Treatment B; Dronabinol oral capsule, under fed conditions; Other Names: Marinol; Drug: Treatment C; Dronabinol oral capsule, under fasted conditions; Other Names: Marinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: INSYS Therapeutics Inc
• Investigators: Study Director: Neha Parikh, INSYS Therapeutics Inc

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 18, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Comparative Bioavailability
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: INS004-15-059