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

Bioavailability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448772
• Other study ID #: INS-10-012
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2011
• Last updated: March 23, 2012
• Start date: October 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: INSYS Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bioavailability

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials Drug Development Solutions	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
INSYS Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and extent of absorption	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	No