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Label indication CELEXA is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . CELEXA is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ). FDA label
Citalopram Hydrobromide · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Citalopram | EXPERIMENTAL | Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's |
| Celexa | ACTIVE_COMPARATOR | Celexa 40 mg Tablets of Forest Labs |
| Name | Type | Description |
|---|---|---|
| Citalopram Hydrobromide | DRUG | Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited |
Inclusion Criteria: Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, Anapharm Inc.Web site, Anaphann Inc. volunteers' data base). Subjects must meet all of the following criteria in order to...
Citalopram Hydrobromide is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development. The specific therapeutic indication for this formulation has not been disclosed. The drug is being evaluated in bioequivalence studies involving healthy adult volunteers.
Citalopram Hydrobromide targets SLC6A4, the serotonin transporter. It acts as an inhibitor of this target. By inhibiting SLC6A4, the drug affects serotonin reuptake. This mechanism is characteristic of its drug class.
Citalopram Hydrobromide is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical trials evaluating this drug candidate.
Citalopram Hydrobromide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 trials have been completed.
Citalopram Hydrobromide has been studied in two completed Phase 1 clinical trials. These are NCT01149980, a bioequivalence study under fed conditions, and NCT01149967, a bioequivalence study under fasting conditions. Both trials enrolled 24 healthy adult volunteers in Canada.