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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06154434
Other study ID # DDS16-065BE
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 6, 2018
Est. completion date February 12, 2019

Study information

Verified date November 2023
Source Whanin Pharmaceutical Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date February 12, 2019
Est. primary completion date February 12, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Main 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 Main 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Chlorpromazine HCl 100mg Tablets
single-dose administered after a 10-hour overnight fast.

Locations

Country Name City State
Korea, Republic of Whan In Pharm. Seoul

Sponsors (1)

Lead Sponsor Collaborator
Whanin Pharmaceutical Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUClast Up to 72 hours
Primary Cmax Up to 72 hours
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