Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

Phase 1

Completed

• Conditions: To Determine Bioequivalence Under Fasting Conditions
• Interventions: Drug: Dronabinol; Drug: Marinol

• Registration Number: NCT01380457
• Lead Sponsor: Par Pharmaceutical, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2011-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-22
• Last Update Submitted: 2011-06-22
• Study First Posted: 2011-06-27
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Dronabinol	Subjects received the test formulated product manufactured by Pharmaceutics International, Inc. and marketed by Par Pharmaceutical, Inc. under fasting conditions
B	Marinol	Subjects received the reference listed drug manufactured by Banner Pharmacaps, Inc. and marketed by Unimed Pharmaceutical, Inc.

Primary Outcome Measures

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

Trial Locations

Locations (1)

BASi; 🇺🇸 Baltimore, Maryland, United States