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Effexor

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials5
Total Enrollment114

FDA Designations

No designations recorded

Clinical trial landscape

Effexor · 5 trials · 1 indication

Phase 1 5
NCT01282814Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle StudyHealthy
COMPLETED24 Analytics
NCT00834249Venlafaxine 25 mg Tablets Under Non-Fasting ConditionsHealthy
COMPLETED18 Analytics
NCT00834964Venlafaxine 25 mg Tablets Under Fasting ConditionsHealthy
COMPLETED30 Analytics
NCT01260896Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting ConditionsHealthy
COMPLETED24 Analytics
NCT01282801Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fed ConditionsHealthy
COMPLETED18 Analytics
PHASE1COMPLETED
Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study
HealthyUnlock trial analytics
PHASE1COMPLETED
Venlafaxine 25 mg Tablets Under Non-Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Venlafaxine 25 mg Tablets Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fed Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax of Venlafaxine.
Blood samples collected over a 48 hour period.

Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).

AUC0-t of Venlafaxine.
Blood samples collected over a 48 hour period.

Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).

AUC0-inf of Venlafaxine.
Blood samples collected over a 48 hour period.

Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).

Cmax - Maximum Observed Concentration - Venlafaxine in Plasma
Blood samples collected over 24 hour period

Bioequivalence based on Cmax

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma
Blood samples collected over 24 hour period

Bioequivalence based on AUC0-inf

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma
Blood samples collected over 24 hour period

Bioequivalence based on AUC0-t

Secondary Endpoints

Cmax - O-Desmethylvenlafaxine in Plasma
Blood samples collected over 24 hour period
AUC0-inf - O-desmethylvenlafazine in Plasma
Blood samples collected over 24 hour period
AUC0-t - O-desmethylvenlafaxine in Plasma
Blood samples collected over 24 hour period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Investigational Test ProductEXPERIMENTALVenlafaxine Hydrochloride 150 mg Extended-Release Capsules.
Reference Listed DrugACTIVE_COMPARATOREffexor® XR 150 mg Extended-Release Capsules
VenlafaxineEXPERIMENTALVenlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
Effexor®ACTIVE_COMPARATOREffexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period

Interventions

NameTypeDescription
Venlafaxine HydrochlorideDRUG150 mg Extended-Release Capsule
Effexor® XRDRUG150 mg Extended-Release Capsule
Venlafaxine 25 mg TabletsDRUG1 x 25 mg, single-dose fasting
Effexor® 25 mg TabletsDRUG1 x 25 mg, single-dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Members of the community at large. * Subjects will be females and/or males, non-smokers, 18 years of age and older. * Female subjects will be postmenopausal or surgically sterilized. Exclusion Criteria: * Clinically significant illness within 4 weeks of the administration of...

Countries:Canada
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Frequently asked questions about Effexor

What is Effexor?

Effexor is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers for research purposes, with completed trials focusing on the pharmacokinetics of venlafaxine tablets and extended-release capsules.

What is Effexor used for?

Effexor is being studied in healthy volunteers as part of Phase 1 clinical trials. These trials are designed to evaluate the drug's absorption and effects under fasting and fed conditions, as well as a sprinkle administration study. The drug is not yet approved for any specific medical condition.

Who makes Effexor?

Effexor is being developed by Teva Pharmaceutical Industries Limited, a company traded under the ticker TEVA. Teva is conducting Phase 1 clinical trials of the drug in healthy volunteers in Canada, with all five trials completed.

What phase is Effexor in?

Effexor is in Phase 1 clinical development. All five clinical trials associated with the drug are completed, with no active trials currently ongoing. The trials enrolled a total of 114 healthy participants and were conducted in Canada.

What clinical trials is Effexor in?

Effexor has five completed Phase 1 clinical trials, including NCT00834964, NCT01260896, NCT01282801, and NCT01282814. These studies evaluated venlafaxine 25 mg tablets and 150 mg extended-release capsules under fasting, fed, and sprinkle conditions in healthy volunteers.

Is Effexor the same as venlafaxine?

Effexor is the brand name for venlafaxine, a small molecule drug. The clinical trials for Effexor are listed under the generic name venlafaxine, including studies of venlafaxine 25 mg tablets and venlafaxine hydrochloride 150 mg extended-release capsules.