Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Objective:
Study Design:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline Hydrochloride | Drug |
Inclusion Criteria:
Exclusion Criteria:
Clinically significant illness or surgery within 4 weeks prior to the administration of the study medication.
Positive testing for hepatitis B, hepatitis C, or HIV at screening.
ECG abnormalities or vital sign abnormalities(blood pressure).
History of significant alcohol or drug abuse within one year prior to the screening visit.
History or allergic reactions to heparin, sertraline or other related drugs.
Use of an investigational drug or participation in an investigational study with in 30 days prior to administration of the study medication.
Clinically significant history of gastrointestinal pathology, liver or kidney disease, neurological, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
History of seizures, suicide attempt, bipolar disorder or manic episodes.
Depot injection or an implant of any drugs with in 6 months prior to administration of study medication.
Breastfeeding subject.
Positive urine pregnancy test at screening.
Female subject of child bearing potential having unprotected sexual intercourse with any non-sterile mail partner within 14 days prior to study drug administration. Acceptable methods of contraception:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anapharm Inc. | Montreal | Quebec | Canada |
Not provided
| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
Not provided
Not provided
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |