Kyusyu Region, Japan
NCT Number: NCT02875080
Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects
The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).
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Notify MeKey information
Conditions
Age range
20 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 or sponsor may place the subject at risk or interfere with outcome variables, including 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 an investigational drug within 120 days prior to the first dosing of trial drug
- Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to screening
- Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, starfruit, or starfruit products within 72 hours prior to dosing
- Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or St. John's Wort within 14 days prior to the first dosing of trial drug, or of antibiotics within 30 days prior to the first dosing of trial drug
- History of major surgery of the digestive tract (excluding appendectomy)
- Any subject who, in the opinion of the investigator, should not participate in the trial
Treatment and study plan
OPC-34712
DrugOther names: Brexpiprazole
Primary outcomes
-
Maximum Plasma Concentration (Cmax) of OPC-34712
Time frame: Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120,144, 168, 216, 264, and 312 hours postdose
To evaluate Cmax of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation
-
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) of OPC-34712
Time frame: Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120,144, 168, 216, 264, and 312 hours postdose
To evaluate AUC∞ of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation
Sponsors and collaborators
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Industry
Registry information
Official study title
A Single-center, Open-label, Randomized, Three-way, Crossover Trial to Evaluate the Bioavailability of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets Relative to Brexpiprazole (OPC-34712) Conventional Tablets in Healthy Male Subjects
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Aug 23, 2016
- Registry last updated
- Feb 23, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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