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

Healthy Subject Clinical Trial

Official title:

An Open Label, Randomized, Fasting, Single-dose, Two-period Crossover Study to Compare the Bioequivalence of Chlorpromazine HCl 100mg Tablets After Oral Administration in Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06154434
• Other study ID #: DDS16-065BE
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy Subject

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