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

Whanin Pharmaceutical Company

Status and phase: Completed; Phase 1

Conditions: Healthy Subject

Treatments: Drug: Chlorpromazine HCl 100mg Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06154434

DDS16-065BE

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Group A

Experimental group

Treatment:

Drug: Chlorpromazine HCl 100mg Tablets

Group B

Experimental group

Treatment:

Drug: Chlorpromazine HCl 100mg Tablets