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Amaryl

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Amaryl · 2 trials · 1 indication

Phase 1 2
NCT00648362Fasting Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mgHealthy
COMPLETED40 Analytics
NCT00650533Food Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mgHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
Fasting Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Food Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALGlimepiride Tablets 1 mg
2ACTIVE_COMPARATORAmaryl® Tablets 1 mg

Interventions

NameTypeDescription
Glimepiride Tablets 1 mgDRUG1mg, single dose fasting
Amaryl® Tablets 1 mgDRUG1mg, single dose fasting
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Eligibility Criteria

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

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. a. Women of childbearing potential must have a negative serum (Beta HCG) pregnancy test performed within 14 days prior to the start of the study and on the evening prior to each dose administrati...

Countries:United States
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Frequently asked questions about Amaryl

What is Amaryl used for?

Amaryl is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials evaluating its pharmacokinetics. The drug is being developed by Viatris Inc. and is not yet approved for any indication.

Who makes Amaryl?

Amaryl is being developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. The drug is currently in Phase 1 clinical trials, and Viatris is the developer responsible for its clinical program.

What phase is Amaryl in?

Amaryl is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities, as it is still in the early stages of clinical testing.

What clinical trials is Amaryl in?

Amaryl has two completed Phase 1 clinical trials: NCT00648362, a fasting study comparing glimepiride tablets 1 mg to Amaryl tablets 1 mg, and NCT00650533, a food study with the same comparison. Both trials enrolled 40 healthy volunteers each in the United States.

Is Amaryl the same as glimepiride?

Amaryl is being studied in comparison to glimepiride tablets in clinical trials. The trials are designed to evaluate the pharmacokinetics of Amaryl tablets 1 mg against glimepiride tablets 1 mg under fasting and fed conditions. The drug is currently in Phase 1 development.