Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions

March 23, 2012 updated by: INSYS Therapeutics Inc

A Single-Dose, Replicate Crossover Design Comparative Bioavailability Study of Dronabinol Oral Solution 5 mg Versus Marinol Capsules 5 mg Under Fasted Conditions

This is a comparative study to assess bioavailability of a proposed alternate dosage form against the current FDA-approved branded product.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78754
        • Worldwide Clinical Trials Drug Development Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female healthy subjects between 18 and 55 years of age, inclusive.
  2. Subjects must have a body mass index (BMI) within 19 and 29.9 kg/m2, inclusive and weigh a minimum of 50 kg (110 pounds).
  3. Subjects must be in general good health as determined by medical history, physical examination, or laboratory evaluations conducted at the screening visit and upon admission to the clinic. Examination should include a thorough examination of oral cavity for any abnormal findings.
  4. Subjects must be non-smokers, defined as not having used any tobacco products in the past six months. Negative results from a urine cotinine test conducted at Screening.
  5. Subjects must be able to provide informed consent after risks and benefits have been explained, and be willing to comply with study procedures.
  6. Female subjects of childbearing potential must not be pregnant or nursing; and must be surgically sterile; one year postmenopausal; or on hormonal contraceptive agent(s), diaphragm or condom with spermicidal foam or jelly, or IUD for at least three months prior to drug administration and agree to use the same method of contraception for at least one month after the last drug administration.
  7. Negative urine pregnancy test at screening and prior to drug administration of each period.
  8. Negative HIV 1, hepatitis C virus (HCV) antibody, hepatitis B surface antigen within 30 days prior to the start of the study.
  9. Negative results from screening for drugs of abuse at Screening and Day-1 (check-in) prior to drug administration during all study periods.

Exclusion Criteria:

  1. Known hypersensitivity or allergy to dronabinol, Marinol, marijuana, hashish, or sesame oil.
  2. Have participated in an investigational trial within 30 days or six half-lives of the test drug's biologic activity, whichever is longer, before the time of first study dose in this study.
  3. Presence of visible signs of an infection, mucositis, cold sores, lesions, local irritation, periodontal disease of the oral cavity or any abnormal finding in the oral cavity. In addition, evidence of piercings of the tongue, lip, or anywhere in the oral cavity or a history of oral cavity piercings.
  4. Have donated or received blood or blood products within 30 days prior to the first study dose.
  5. Have received any prescription drug (excluding hormonal contraceptives) within 14 days of study drug administration, over-the-counter drugs within seven days of study drug administration, and/or vitamins or herbal supplements within three days of study drug administration.
  6. Significant bradycardia or tachycardia defined as having a resting heart rate <45 bpm or >100 bpm, respectively.
  7. Clinical evidence of either hypotension (defined as systolic blood pressure <90 mmHg or diastolic blood pressure <50 mmHg), or hypertension (defined as systolic blood pressure >139 mmHg or diastolic blood pressure >89 mmHg).
  8. Any history of clinically significant organ system (cardiovascular, neurological, hepatic, hematopoietic, renal, pulmonary, endocrine, or gastrointestinal) disorders or ongoing infectious diseases; or any other conditions that might interfere with the absorption, distribution, metabolism or excretion of the study drug, or that would place the subject at increased risk.
  9. Use of marijuana (directly or indirectly) within 90 days prior to drug administration and during the course of the study.
  10. History of treatment for alcohol abuse, significant mental illness, physical dependence to any opioid, barbiturates, amphetamines, cocaine, or benzodiazepines in the past 10 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Marinol
Drug: Dronabinol Capsules, 5 mg
Comparison of different routes of administration of a drug using the approved Abbott 5 mg capsule product under fasting conditions; two treatment periods with a washout period separating the study periods
EXPERIMENTAL: oral solution
Drug: Dronabinol Oral Solution
Comparison of different routes of administration of a drug using a proposed oral solution formulation under fasting conditions; two treatment periods with a washout period separating the study periods

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate and extent of absorption
Time Frame: 48 hours
The plasma concentration versus time data of dronabinol and its metabolite (11-hydroxy-delta-9-tetrahydrocannabinol) will be analyzed. The PK parameters Cmax, AUC0-t and AUCinf for delta-9-tetrahydrocannabinol will be calculated and used as the measures for comparative bioavailability assessment of dronabinol oral solution versus the innovator capsule product.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
INSYS Therapeutics Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joe Juren, M.D., Worldwide Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INS-10-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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