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Bioequivalence Study in Healthy Subjects by Using of Chlorpromazine HCl 100mg Tablets

NCT ID: NCT06154434

Last Updated: 2023-12-08

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-06

Study Completion Date

2019-02-12

Brief Summary

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This clinical study is an open label, randomized, fasting condition, single-dose, two-period crossover study to compare the bioequivalence of Chlorpromazine HCl 100mg Tablets after oral administration in healthy subjects.

Detailed Description

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Conditions

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Healthy Subject

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A

Group Type EXPERIMENTAL

Chlorpromazine HCl 100mg Tablets

Intervention Type DRUG

single-dose administered after a 10-hour overnight fast.

Group B

Group Type EXPERIMENTAL

Chlorpromazine HCl 100mg Tablets

Intervention Type DRUG

single-dose administered after a 10-hour overnight fast.

Interventions

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Chlorpromazine HCl 100mg Tablets

single-dose administered after a 10-hour overnight fast.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy subjects, over the age of 19 years old
2. Weight: At least 50.0 kg and Body mass index (BMI) between 18.0-30.0 kg/m2.
3. All subjects should be judged normal and healthy during a pre-study medical evaluation

* Subjects who has no birth or chronic disease and must be in good health as determined by physical exmination and medical tests including biochemistry, urinalysis, serology and hematology etc in serum/urine.
4. Subject is willing to participate and to Sign written informed consent form
5. Female subjects of childbearing age who use contraception other than hormonal contraception.
6. Subjects who has no history of psychical disorder within the last five years

Exclusion Criteria

1. Subjects who have a medical history specified in protocol
2. Subjects who are expected to have the prohibited medication and activity etc. during the study period
3. Subjects who can not comply with requirements as per protocol
4. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy
5. Subjects who are not suitable for the clinical trial
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Whanin Pharmaceutical Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MINGYU PARK

Role: PRINCIPAL_INVESTIGATOR

Chungbuk National University Hospital

Locations

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Whan In Pharm.

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DDS16-065BE

Identifier Type: -

Identifier Source: org_study_id