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Adoxa

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 Trials3
Total Enrollment107

FDA Designations

No designations recorded

Clinical trial landscape

Adoxa · 3 trials · 1 indication

Phase 1 3
NCT00647959Fasting Study of Doxycycline Monohydrate Tablets 150 mg and Adoxa Tablets 150 mgHealthy
COMPLETED36 Analytics
NCT00648180Food Study of Doxycycline Monohydrate Tablets 100 mg and Adoxa Tablets 100 mgHealthy
COMPLETED36 Analytics
NCT00649571Fasting Study of Doxycycline Monohydrate Tablets 100 mg and Adoxa Tablets 100 mgHealthy
COMPLETED35 Analytics
PHASE1COMPLETED
Fasting Study of Doxycycline Monohydrate Tablets 150 mg and Adoxa Tablets 150 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Food Study of Doxycycline Monohydrate Tablets 100 mg and Adoxa Tablets 100 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Doxycycline Monohydrate Tablets 100 mg and Adoxa Tablets 100 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
1EXPERIMENTALDoxycycline Tablets, 150mg
2ACTIVE_COMPARATORAdoxa Tablets 150 mg

Interventions

NameTypeDescription
Doxycycline Tablets, 150mgDRUG150mg, single dose fasting
Adoxa Tablets 150 mgDRUG150mg, single dose fasting
Doxycycline Monohydrate Tablets 100 mgDRUG100mg, single dose fed
Adoxa Tablets 100 mgDRUG100mg, single dose fed
Doxycycline Monohydrate Tablets (100 mgDRUG100mg, 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. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the ev...

Countries:United States
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Frequently asked questions about Adoxa

What is Adoxa?

Adoxa is a small molecule drug being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, with three completed trials involving a total of 107 participants. These trials were conducted in the United States.

What is Adoxa used for?

Adoxa has been studied in healthy volunteers, meaning it is not being tested for a specific disease or condition. The clinical trials for Adoxa focused on pharmacokinetic parameters, such as the effects of food and fasting on the drug's absorption. It is not approved for any medical indication.

Who makes Adoxa?

Adoxa is developed by Viatris Inc., a company traded on the stock exchange under the ticker symbol VTRS. Viatris is the developer of this drug, which is currently in Phase 1 clinical development.

What phase is Adoxa in?

Adoxa is in Phase 1 clinical development. All three of its clinical trials have been completed, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Adoxa in?

Adoxa has been studied in three completed Phase 1 trials: NCT00647959, a fasting study of doxycycline monohydrate tablets 150 mg and Adoxa tablets 150 mg; NCT00648180, a food study of doxycycline monohydrate tablets 100 mg and Adoxa tablets 100 mg; and NCT00649571, a fasting study of doxycycline monohydrate tablets 100 mg and Adoxa tablets 100 mg. All trials enrolled healthy adults aged 18 years and older in the United States.

Is Adoxa the same as doxycycline?

Adoxa is a brand name for doxycycline monohydrate, a type of tetracycline antibiotic. The clinical trials for Adoxa compared it directly with doxycycline monohydrate tablets, indicating that Adoxa is a formulation of doxycycline. However, Adoxa is not approved for any indication and is still in clinical development.