Recent Updates
Recently added Catalysts

Fluoxetine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jul 21, 2010

Target and mechanism

ModalitySmall molecule

Also known as Fluoxetine Hydrochloride

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

Fluoxetine · 2 trials · 1 indication

Phase 1 2
NCT01166087Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules 90 mg of Dr. Reddy's Under Fed ConditionHealthy
COMPLETED54 Analytics
NCT01166100Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Under Fasting ConditionHealthy
COMPLETED54 Analytics
PHASE1COMPLETED
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules 90 mg of Dr. Reddy's Under Fed Condition
Healthy
NCT0116608754
Unlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Under Fasting Condition
Healthy
NCT0116610054
Unlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC parameters
8 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fluoxetine HydrochlorideEXPERIMENTALFluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories Limited
Prozac ® weeklyACTIVE_COMPARATORProzac ® weekly 90 mg delayed release capsules of Eli Lilly and company
Prozac ® weekly TMACTIVE_COMPARATORProzac ® weekly 90 mg delayed release capsules of Eli Lilly and company

Interventions

NameTypeDescription
Fluoxetine HydrochlorideDRUGFluoxetine Hydrocloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:India
Unlock Eligibility Criteria