Status:
COMPLETED
Bioequivalence Study in Healthy Subjects by Using of Chlorpromazine HCl 100mg Tablets
Lead Sponsor:
Whanin Pharmaceutical Company
Conditions:
Healthy Subject
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
December 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06154434
Start Date
December 6 2018
End Date
February 12 2019
Last Update
December 8 2023
Active Locations (1)
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1
Whan In Pharm.
Seoul, South Korea