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Also known as Fluoxetine Hydrochloride
Fluoxetine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Fluoxetine Hydrochloride | EXPERIMENTAL | Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories Limited |
| Prozac ® weekly | ACTIVE_COMPARATOR | Prozac ® weekly 90 mg delayed release capsules of Eli Lilly and company |
| Prozac ® weekly TM | ACTIVE_COMPARATOR | Prozac ® weekly 90 mg delayed release capsules of Eli Lilly and company |
| Name | Type | Description |
|---|---|---|
| Fluoxetine Hydrochloride | DRUG | Fluoxetine Hydrocloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories. |
Inclusion Criteria: * Healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of Life Insurance Corporation of India (11 Underweight and Overweight Min. \& Max. Chart). * Subjects who have no evidence of underlying disease during screening...
Fluoxetine is a small molecule drug candidate developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed, and the two registered trials to date enrolled healthy adult volunteers rather than patients with a named disease.
Fluoxetine targets SLC6A4, the serotonin transporter, and acts as an inhibitor of that target. SLC6A4 regulates serotonin signaling, and inhibition of this transporter is the mechanism assigned to the molecule in this program. The drug is a small molecule modality.
Fluoxetine is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the registered Phase 1 bioequivalence studies of fluoxetine hydrochloride delayed-release capsules, 90 mg.
Fluoxetine is in Phase 1 development. Both registered trials are Phase 1 bioequivalence studies, and both are completed, with no active trials currently listed. The program has not been described as approved, so it remains an investigational asset in clinical development.
Two completed Phase 1 trials are registered for Fluoxetine: NCT01166100, a bioequivalence study of fluoxetine hydrochloride delayed-release capsules, 90 mg, under fasting conditions, and NCT01166087, the same product under fed conditions. Each enrolled 54 healthy volunteers in India, for 108 participants total, with active-controlled, randomized designs.
Yes, Fluoxetine Hydrochloride is an alternative name for Fluoxetine. The registered trials use the hydrochloride salt form, specifically fluoxetine hydrochloride delayed-release capsules at 90 mg, so searches for either name refer to the same drug substance and development program.