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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorpromazine HCl 100mg Tablets | Drug | single-dose administered after a 10-hour overnight fast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | Up to 72 hours | |
| Cmax | Up to 72 hours |
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Main 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
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:
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| Name | Affiliation | Role |
|---|---|---|
| MINGYU PARK | Chungbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Whan In Pharm. | Seoul | South Korea |
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| ID | Term |
|---|---|
| D002746 | Chlorpromazine |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |