Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions - Full Text View

Purpose

The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg capsules verses Marinol.

Condition	Intervention	Phase
To Determine Bioequivalence Under Fasting Conditions	Drug: Dronabinol Drug: Marinol	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	A Comparative Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

Resource links provided by NLM:

Drug Information available for: Dronabinol

U.S. FDA Resources

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:

Bioequivalence [ Designated as safety issue: No ]
To conclude bioequivalence; 90% geometric confidence interval was contained within the limits 0.8 to 1.25.

Enrollment:	69
Study Start Date:	January 2006
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Subjects received the test formulated product manufactured by Pharmaceutics International, Inc. and marketed by Par Pharmaceutical, Inc. under fasting conditions	Drug: Dronabinol Capsules, 10 mg, single dose, fasting conditions Other Name: Marinol
Active Comparator: B Subjects received the reference listed drug manufactured by Banner Pharmacaps, Inc. and marketed by Unimed Pharmaceutical, Inc.	Drug: Marinol Capsules, 10 mg, single-dose, fasting conditions Other Name: Dronabinol

Detailed Description:

To compare the plasma levels of dronabinol (delta-9-tetrahydrocannabinol)and the principle active metabolite 11-OH-delta-9-tetrahydrocannabinol levels produced after administration of the test formulation with those produced after administration of a marketed reference product, under fasted conditions.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers, 18 - 55 years of age
Subjects must be within 18 to 29.9 kilograms/m2 per the BMI
General good health as determined by medical history and physical examination within 30 days prior to the start of the study
Blood chemistry, hematology, and urinalysis tests will be performed within 30 days prior to the start of the study
No participation in an investigational drug study or donation of blood within 30 days prior to the start of the study
At screening, subjects must have blood pressure and pulse rate within specified ranges
No grapefruit juice or grapefruit-containing products for at least 72 hours prior to drug administration, each period. Subjects will be queried at check-in each period on consumption of grapefruit juice or grapefruit containing products. Results will be recorded and reported in the final report.
No alcohol consumption for at least 24 hours prior to drug administration, each period
No caffeine or xanthine consumption for 48 hours prior prior to drug administration, each period
No prescription drugs (excluding hormonal contraceptives) within 14 days prior to drug administration, each period
Subjects should refrain from taking OTC preparations, and/or nutritional supplements within 7 days prior to drug administration, each period. Subjects shall refrain from taking herbal remedies within 14 day prior to drug administration, and throughout the study periods
Female subjects must not be pregnant or nursing; and must be surgically sterile; one year post-menopausal; or on hormonal contraceptive agents), a diaphragm or condom with spermicidal foam or jelly, or IUD for at least 3 months prior to drug administration and agree to use the same method of contraception for at least 1 month after the last drug administration
Negative serum pregnancy test at screening and negative urine pregnancy test prior to drug administration, each period
Negative HIV 1, hepatitis B surface antigen, an urine screen for drugs of abuse within 30 days prior to the start of the study

Exclusion Criteria:

Disease or condition that could impact interpretation of study results or a condition which treatment would be contraindicated per currently approved product labeling
Subjects had any of the following conditions:
- used any prescription or OTC medication within 14 days of study initiation
- a positive urine test for illicit drugs
- participated in a clinical investigation within the past 30 days
- had clinically significant allergies to drugs or foods, ot
- any condition that might place them at increased risk of complications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380457

Locations

United States, Maryland
BASi
Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

Par Pharmaceutical, Inc.

BASi Clinical Research Unit

Investigators

Principal Investigator:

Dilip K Guha-Ray, M.D.

BASi Baltimore Clinical Research Unit

More Information

No publications provided

Responsible Party:	Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT01380457 History of Changes
Other Study ID Numbers:	11885
Study First Received:	June 16, 2011
Last Updated:	June 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Par Pharmaceutical, Inc.:

bioequivalence
dronabinol
fasting

Additional relevant MeSH terms:

Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013