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Trial record 14 of 56 for:    insys

Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02604992
Recruitment Status : Completed
First Posted : November 16, 2015
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Treatment A Drug: Treatment B Drug: Treatment C Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : November 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

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 Name: Marinol

Drug: Treatment C
Dronabinol oral capsule, under fasted conditions
Other Name: 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 Name: Marinol

Drug: Treatment C
Dronabinol oral capsule, under fasted conditions
Other Name: 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 Name: Marinol

Drug: Treatment C
Dronabinol oral capsule, under fasted conditions
Other Name: 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 Name: Marinol

Drug: Treatment C
Dronabinol oral capsule, under fasted conditions
Other Name: 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 Name: Marinol

Drug: Treatment C
Dronabinol oral capsule, under fasted conditions
Other Name: 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 Name: Marinol

Drug: Treatment C
Dronabinol oral capsule, under fasted conditions
Other Name: Marinol




Primary Outcome Measures :
  1. Area under the curve from time 0 to the last measured concentration [ Time Frame: 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. ]
  2. Area under the curve extrapolated to infinity [ Time Frame: 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. ]
  3. Maximum plasma concentration [ Time Frame: 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. ]
  4. Time to reach maximum plasma concentration [ Time Frame: 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. ]
  5. Elimination rate constant [ Time Frame: 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. ]
  6. The time prior to the first measurable (non-zero) concentration [ Time Frame: 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. ]
  7. Elimination half-life [ Time Frame: 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. ]
  8. Apparent oral clearance [ Time Frame: 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. ]
  9. Volume of distribution [ Time Frame: 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. ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604992


Locations
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United States, Texas
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Study Director: Neha Parikh INSYS Therapeutics Inc

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Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02604992     History of Changes
Other Study ID Numbers: INS004-15-059
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by INSYS Therapeutics Inc:
Comparative Bioavailability
Additional relevant MeSH terms:
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Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists