Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

To Determine Bioequivalence Under Fasting Conditions Clinical Trial

Official title:

A Comparative Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380457
• Other study ID #: 11885
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2011
• Last updated: June 22, 2011
• Start date: January 2006
• Est. completion date: April 2006

Study information

• Verified date: June 2011
• Source: Par Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Disease
• To Determine Bioequivalence Under Fasting Conditions

Intervention

Drug:
• Dronabinol
Capsules, 10 mg, single dose, fasting conditions
• Marinol
Capsules, 10 mg, single-dose, fasting conditions

Locations

Country	Name	City	State
United States	BASi	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Par Pharmaceutical, Inc.	BASi Clinical Research Unit

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence	To conclude bioequivalence; 90% geometric confidence interval was contained within the limits 0.8 to 1.25.		No