Comparative Bioavailability Study of Aripiprazole 10 mg Oral Soluble Film vs Abilify® 10 mg Tablet in Healthy Volunteers

A Single-dose, Randomized, Three-period, Crossover Comparative Bioavailability Study of a Novel Formulation of Aripiprazole 10 mg Oral Soluble Film vs the Marketed Formulation Abilify® 10 mg Tablet in Healthy Volunteers

The purpose of this study is to compare the rate and extent of absorption of Aripiprazole Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male volunteers

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Aripiprazole

Detailed Description

The proposed study is a single centre, bioavailability, open-label, randomized, single-dose, 3-period, 6-sequence, crossover study under fasting conditions. Each volunteer will be given a single dose of the Test formulation in two study periods (with and without water), and a single dose of the Reference formulation (with water) in the other study period.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, moderate smoker (no more than 9 cigarettes daily) or non-smoker, ≥45 and ≤65 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight 50.0 kg for males and 45.0 kg for females.
2. Healthy as defined by:
3. Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 42 days after the last study drug administration:
4. Capable of consent.

Exclusion Criteria:

1. Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
2. Positive urine drug screen at screening.
3. History of allergic reactions to aripiprazole, dimenhydrinate, benztropine, diphenhydramine or other related drugs.
4. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration.
5. Positive pregnancy test at screening.
6. Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
7. Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm), decrease in systolic blood pressure of 20 mmHg or higher, or decrease in diastolic blood pressure of 10 mmHg or higher within 2 to 3 minutes after passing from a supine to a standing position, at screening.
8. History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
9. History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine (PCP), and crack) within 1 year prior to screening.
10. Use of aripiprazole for a medical condition or in the context of another clinical trial within a period of 42 days prior to the first dosing.
11. Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics) prior to the first dosing or concomitant participation in an investigational study involving no drug administration.

12. Use of medication other than topical products without significant systemic absorption and hormonal contraceptives:

    • prescription medication within 14 days prior to the first dosing;
    • over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
    • a depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to the first dosing.
13. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
14. Hemoglobin <128 g/L (males) and <115 g/L (females) and hematocrit <0.37 L/L (males) and <0.32 L/L (females) at screening.
15. Breast-feeding subject.
16. HAM-D-7 scale score above 3 at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Healthy volunteers will receive Aripiprazole Oral Soluble Film(OSF) 10mg orally a single of dose within 28 days with water.	Drug: Aripiprazole; Healthy volunteers will receive Aripiprazole Oral Soluble Fim(OSF) 10mg orally a single of dose within 28 days; Other Names: Abilify® 10 mg tablet
Experimental: Group B; Healthy volunteers will receive Aripiprazole Oral Soluble Film(OSF) 10mg orally a single of dose within 28 days without water.	Drug: Aripiprazole; Healthy volunteers will receive Aripiprazole Oral Soluble Fim(OSF) 10mg orally a single of dose within 28 days; Other Names: Abilify® 10 mg tablet
Experimental: Gruop C; Healthy volunteers will receive the reference drug Abilify tab. 10mg orally a single of dose within 28 days with water.	Drug: Aripiprazole; Healthy volunteers will receive Aripiprazole Oral Soluble Fim(OSF) 10mg orally a single of dose within 28 days; Other Names: Abilify® 10 mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate extent of absorption of aripiprazole OSF 10mg versus Abilify ® 10mg tablet	Baseline to 28 days

Collaborators and Investigators

• Sponsor: CMG Pharmaceutical Co. Ltd
• Investigators: Study Director: Byung Jo Kim, M.D., Development Div.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Schizophrenia; Aripiprazole; Oral Soluble Film
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: CMG-ARI-140052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes