Recent Updates
Recently added Catalysts

Femara

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Dec 1, 2009

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Femara · 2 trials · 1 indication

Phase 1 2
NCT00648063Fasting Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mgHealthy
COMPLETED24 Analytics
NCT00648154Food Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mgHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Fasting Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
Healthy
NCT0064806324
Unlock trial analytics
PHASE1COMPLETED
Food Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
Healthy
NCT0064815424
Unlock trial analytics

Study Endpoints

Primary Endpoints

The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
Blood collections through 216 hours
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLetrozole Tablets 2.5 mg
2ACTIVE_COMPARATORFemara® Tablets 2.5 mg

Interventions

NameTypeDescription
Letrozole Tablets 2.5 mgDRUG2.5mg, single dose fasting
Femara® Tablets 2.5 mgDRUG2.5mg, single dose fasting
Unlock Study Design Details

Eligibility Criteria

Age Range40 Years to N/A
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 40 years or older. 2. Sex: Females only. 3. Weight: At least 52 kg (115 lbs) and within 30% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HU...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Femara

What is Femara used for?

Femara is a small molecule drug being studied in healthy female volunteers. It is currently in Phase 1 clinical development, with two completed trials evaluating the drug in healthy postmenopausal women. Femara is being developed by Viatris Inc. (NASDAQ: VTRS).

What does Femara target?

Femara is a small molecule drug. The specific molecular target of Femara is not disclosed in the available clinical trial information. The drug is being studied in healthy volunteers to assess its pharmacokinetics and bioavailability.

Who makes Femara?

Femara is being developed by Viatris Inc., a global healthcare company traded on NASDAQ under the ticker symbol VTRS. The company is conducting clinical trials to evaluate Femara in healthy female subjects.

What phase is Femara in?

Femara is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy female volunteers aged 40 years and older. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Femara in?

Femara has been studied in two completed Phase 1 clinical trials: NCT00648063, a fasting study comparing letrozole tablets 2.5 mg to Femara tablets 2.5 mg, and NCT00648154, a food study with the same comparison. Both trials enrolled 24 healthy female subjects each in the United States.

Is Femara the same as letrozole?

Femara is being studied as a reference product in clinical trials comparing it to generic letrozole tablets. The trials are designed to evaluate bioequivalence between Femara and letrozole 2.5 mg tablets under fasting and fed conditions.