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Doxycycline

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as Doxycycline Monohydrate

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Doxycycline · 2 trials · 1 indication

Phase 1 2
NCT00829764Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fasting ConditionsHealthy
COMPLETED30 Analytics
NCT00829790Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed ConditionsHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fasting Conditions
Healthy
NCT0082976430
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PHASE1COMPLETED
Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions
Healthy
NCT0082979030
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Study Endpoints

Primary Endpoints

Cmax = Maximum Observed Concentration.
Blood samples collected over a 72 hour period.

Bioequivalence based on Cmax.

AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-inf.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDoxycycline Monohydrate
2ACTIVE_COMPARATORVibramycin Monohydrate®

Interventions

NameTypeDescription
Doxycycline MonohydrateDRUG25 mg 5 mL dose
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Eligibility Criteria

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

Inclusion Criteria All subjects must satisfy the following criteria to be considered for study participation: * Subject must be male or non-pregnant, non-breast-feeding female * Subject must be at least 18 years of age * Subject must have a Body Mass Index (BMI) between 18 and 30 kg/m2, inclusive,...

Countries:United States
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