Bioequivalence Study in Healthy Subjects by Using of Chlorpromazine HCl 100mg Tablets
- Registration Number
- NCT06154434
- Lead Sponsor
- Whanin Pharmaceutical Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
-
Healthy subjects, over the age of 19 years old
-
Weight: At least 50.0 kg and Body mass index (BMI) between 18.0-30.0 kg/m2.
-
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.
-
Subject is willing to participate and to Sign written informed consent form
-
Female subjects of childbearing age who use contraception other than hormonal contraception.
-
Subjects who has no history of psychical disorder within the last five years
Main
Exclusion Criteria
- Subjects who have a medical history specified in protocol
- Subjects who are expected to have the prohibited medication and activity etc. during the study period
- Subjects who can not comply with requirements as per protocol
- Pregnant women or breast-feeding women or men and women who has possibility of pregnancy
- Subjects who are not suitable for the clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group A Chlorpromazine HCl 100mg Tablets - Group B Chlorpromazine HCl 100mg Tablets -
- Primary Outcome Measures
Name Time Method AUClast Up to 72 hours Cmax Up to 72 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Whan In Pharm.
🇰🇷Seoul, Korea, Republic of