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The purpose of this study is to evaluate the PK properties in fed and fasted men and women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorcaserin 10mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin 10mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetic properties of a single oral dose of lorcaserin in the fed versus fasted state |
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Inclusion Criteria:
Exclusion Criteria:
Prior participation in any study of lorcaserin.
Clinically significant new illness in the 1 month before screening
Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
History of any of the following cardiovascular conditions:
Positive result of HIV, hepatitis B or hepatitis C screens
Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
Initiation of a new prescription medication within 1 month prior to screening.
Recent history (within 2 years prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening.
Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
Use of SSRIs,SNRIs, and other medications must meet the washout period.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRI Worldwide | Willingboro | New Jersey | 08046 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |