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Trial record 4 of 948 for:    tablet | Japan

Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg

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ClinicalTrials.gov Identifier: NCT03902574
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg

Condition or disease Intervention/treatment Phase
Healthy Adult Male Drug: Brexpiprazole ODT 2mg with water Drug: Brexpiprazole ODT 2mg without water Drug: Brexpiprazole conventional tablet 2mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Open-label, Randomized, 3-arm, 3-way, Crossover Trial to Investigate the Bioequivalence of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets in Healthy Adult Males
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brexpiprazole ODT 2mg with water
Brexpiprazole ODT 2mg is administered with water.
Drug: Brexpiprazole ODT 2mg with water
Brexpiprazole ODT 2mg is administered with water.
Other Name: OPC-34712 OD

Experimental: Brexpiprazole ODT 2mg without water
Brexpiprazole ODT 2mg is administered without water.
Drug: Brexpiprazole ODT 2mg without water
Brexpiprazole ODT 2mg is administered without water.
Other Name: OPC-34712 OD

Experimental: Brexpiprazole conventional tablet 2mg
Brexpiprazole conventional tablet 2mg is administered with water.
Drug: Brexpiprazole conventional tablet 2mg
Brexpiprazole conventional tablet 2mg is administered with water.
Other Name: OPC-34712 conventional tablet




Primary Outcome Measures :
  1. Measure the Maximum (Peak) plasma concentration of the drug (Cmax) [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours postdose ]
  2. Area under the concentration-time curve calculated to the last observable concentration at time t (AUCt) [ Time Frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose ]


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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese males
  • BMI [body weight in kg /(height in m)2] of at least 18.5 kg/m2 and less than 25.0 kg/m2 (as a result of at the screening examination)
  • Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial

Exclusion Criteria:

  • Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator, subinvestigator, or sponsor may place the subject at risk or interfere with outcome variables such as drug absorption, distribution, metabolism, and excretion
  • History of serious mental disorder
  • History of drug or alcohol abuse within 2 years prior to screening
  • History of any significant drug allergy
  • Use of another investigational drug within 120 days prior to the first administration of IMP
  • Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, Star fruit, or Star fruit products within 72 hours prior to the first administration of IMP or consumption of alcohol within 72 hours prior to administration of IMP
  • Use of prescription, over-the-counter (OTC), or herbal medication, or vitamin supplements, or consumption of food or beverages containing St. John's Wort within 14 days prior to the first administration of IMP, or use of antibiotics within 30 days prior to the first administration of IMP
  • History of major surgery of the digestive tract (excluding appendectomy)
  • Any subject who, in the judgement of the investigator or subinvestigator, should not participate in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902574


Contacts
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Contact: Drug Information Center +81-3-6361-7314

Locations
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Japan
SOUSEIKAI Hakata clinic Recruiting
Fukuoka, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Osamu Sato Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03902574     History of Changes
Other Study ID Numbers: 331-14-002
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents