Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers

INSYS Therapeutics

Status: Completed

Conditions: Healthy

Treatments: Drug: Treatment B; Drug: Treatment A; Drug: Treatment C

Study type: Interventional

Funder types: Industry

Identifiers

NCT02604992

INS004-15-059

Details and patient eligibility

About

The primary objective of this study is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (RLD) administered to participants under fed and fasted conditions.

The secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.

Enrollment: 54 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Meets protocol-specified criteria for qualification
• Fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the Investigator and study coordinator

Exclusion criteria

• History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters

• Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 6 patient groups

Group 1 (A,B,C)

Experimental group

Description:

With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C.

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A

Group 2 (B,C,A)

Experimental group

Description:

With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A.

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A

Group 3 (C,A,B)

Experimental group

Description:

With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B.

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A

Group 4 (C,B,A)

Experimental group

Description:

With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A.

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A

Group 5 (A,C,B)

Experimental group

Description:

With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B.

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A

Group 6 (B,A,C)

Experimental group

Description:

With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C.

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A