Healthy Subject
Conditions
Brief 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.
Interventions
DRUGChlorpromazine HCl 100mg Tablets
single-dose administered after a 10-hour overnight fast.
Sponsors
Whanin Pharmaceutical Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast | Up to 72 hours |
| Cmax | Up to 72 hours |
Countries
South Korea
Outcome results
None listed