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Bioequivalence Test for Risperdal 2mg of Janssen Korea

NCT ID: NCT02012049

Last Updated: 2013-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study was to conduct the bioequivalence (biological equivalence of two preparations of a drug) test in healthy adults with "Risperdal OD Tab. 2mg" of Janssen Korea as the investigational drug and "Risperdal Quicklet Tab. 2mg" as the control drug.

Detailed Description

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This was a randomized (the study drug is assigned by chance) and open labeled (all people know the identity of the intervention) study. All participants were hospitalized in research rooms and were subsequently restricted in exercise, eating, drinking, smoking and xanthine-beverages until the end of blood collection. Water was allowed to be taken until one hour before drug administration. Participants were randomly assigned into two groups, one group receiving Risperdal OD (investigational drug), and one group receiving Risperdal Quicklet (control drug). On the day of testing, blood was collected from all participants to provide baseline measurements. Subsequently, the study drug was orally administered to the participants, followed by blood collection of a total of 13 time points, up to 24 hours. After the blood collection was finished, participants were discharged after receiving proper guidance and being examined by a psychologist. Following a wash-out period (period when receiving no intervention) of one week, participants were hospitalized once more and crossed over to receive the study drugs following the same procedure above described. The approximate study duration (including the drug administration days and wash-out period) was approximately 10 days.

Conditions

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Healthy

Keywords

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Healthy Risperdal OD Risperdal Quicklet Korea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Risperdal OD / Risperdal Quicklet

Risperdal OD (investigational drug) + Risperdal Quicklet (control drug)

Group Type EXPERIMENTAL

Risperdal OD Tab. 2mg

Intervention Type DRUG

1 tablet Risperdal OD 2 mg administered orally.

Risperdal Quicklet Tab. 2mg

Intervention Type DRUG

1 tablet Risperdal Quicklet Tab. 2mg administered orally.

Risperdal Quicklet / Risperdal OD

Risperdal Quicklet (control drug) + Risperdal OD (investigational drug)

Group Type EXPERIMENTAL

Risperdal OD Tab. 2mg

Intervention Type DRUG

1 tablet Risperdal OD 2 mg administered orally.

Risperdal Quicklet Tab. 2mg

Intervention Type DRUG

1 tablet Risperdal Quicklet Tab. 2mg administered orally.

Interventions

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Risperdal OD Tab. 2mg

1 tablet Risperdal OD 2 mg administered orally.

Intervention Type DRUG

Risperdal Quicklet Tab. 2mg

1 tablet Risperdal Quicklet Tab. 2mg administered orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Korean participants weighing more than 50kg and within 20% normal lean body weight (standard weight)
* Participant without congenital or chronic diseases and with no symptoms or findings as a result of internal examination
* Participant who was deemed appropriate as a result of inquiry, blood pressure, physical examination, electrocardiogram, blood and urinalysis, etc., within 28 days prior to the first administration of the investigational drug according to the protocol
* Female participant who was confirmed as non-pregnant through urine test during health examination

Exclusion Criteria

* Participant who had a history of disease related to cardiac, respiratory, hepatic, renal, gastrointestinal or nervous system, or cardiac infarction, stroke, hypertension, arrhythmia, coronary artery disease, or neuropsychiatric diseases that could affect drug absorption, distribution, metabolism and excretion or could be risk factors when taking drugs used for the clinical trial, a history of gastrointestinal surgery except appendectomy or herniotomy, or who currently had abnormality in inquiry or physical examination
* Participant who showed symptoms that were suspected as acute disease within 14 days from the first administration of the investigational drug
* Participant with allergic disease requiring treatment
* Participant who had a history of being hypersensitive to drugs or food
* Patient who had hepatitis B antigen or who showed hepatitis C positive antigen
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Other Identifiers

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RISSCH1015

Identifier Type: OTHER

Identifier Source: secondary_id

RIS-KOR-1083

Identifier Type: OTHER

Identifier Source: secondary_id

CR016576

Identifier Type: -

Identifier Source: org_study_id