Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

NCT01380457 | Completed Phase 1

• 1 other identifier: 11885
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

To Determine Bioequivalence Under Fasting Conditions

Keywords

bioequivalence; dronabinol; fasting

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  To conclude bioequivalence; 90% geometric confidence interval was contained within the limits 0.8 to 1.25.

Study Arms (2)

A

EXPERIMENTAL

Subjects received the test formulated product manufactured by Pharmaceutics International, Inc. and marketed by Par Pharmaceutical, Inc. under fasting conditions

Drug: Dronabinol

B

ACTIVE COMPARATOR

Subjects received the reference listed drug manufactured by Banner Pharmacaps, Inc. and marketed by Unimed Pharmaceutical, Inc.

Drug: Marinol

Interventions

Dronabinol DRUG

Capsules, 10 mg, single dose, fasting conditions

Also known as: Marinol

A

Marinol DRUG

Capsules, 10 mg, single-dose, fasting conditions

Also known as: Dronabinol

B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• BASi Clinical Research Unit: collaborator

Study Sites (1)

BASi

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Fasting

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Dilip K Guha-Ray, M.D.

  BASi Baltimore Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 27, 2011
• Study Start: January 1, 2006
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

US (1)