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Moexipril/hydrochlorothiazide 15

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Moexipril/hydrochlorothiazide 15 · 2 trials · 1 indication

Phase 1 2
NCT00834067Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-Fasting ConditionsHealthy
COMPLETED60 Analytics
NCT00835042Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting ConditionsHealthy
COMPLETED60 Analytics
PHASE1COMPLETED
Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.
Blood samples collected over a 192 hour period.

Bioequivalence based on Cmax.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.
Blood samples collected over a 192 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.
Blood samples collected over a 192 hour period.

Bioequivalence based on AUC0-inf.

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.
Blood samples collected over a 192 hour period.

Bioequivalence based on Cmax.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.
Blood samples collected over a 192 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.
Blood samples collected over a 192 hour period.

Bioequivalence based on AUC0-inf.

Secondary Endpoints

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.
Blood samples collected over a 192 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.
Blood samples collected over a 192 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.
Blood samples collected over a 192 hour period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Moexipril HCl/hydrochlorothiazide 15/25 mg tabletsDRUG1 x 15/25 mg
UNIRETIC® 15/25 mg tabletsDRUG1 x 15/25 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years of age. * Subjects will have a BMI index (body mass index) of 30 or less. Exclusion Criteria: * Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious...

Countries:United States
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Frequently asked questions about Moexipril/hydrochlorothiazide 15

What is Moexipril/hydrochlorothiazide 15 used for?

Moexipril/hydrochlorothiazide 15 is an investigational small molecule being studied in healthy volunteers. It is a combination product containing moexipril and hydrochlorothiazide, and it is currently in Phase 1 clinical development. The drug is being evaluated for its pharmacokinetic profile under fasting and non-fasting conditions.

Who makes Moexipril/hydrochlorothiazide 15?

Moexipril/hydrochlorothiazide 15 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker TEVA. Teva is conducting Phase 1 clinical trials to evaluate the drug's behavior in healthy subjects.

What phase is Moexipril/hydrochlorothiazide 15 in?

Moexipril/hydrochlorothiazide 15 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, both involving healthy volunteers in the United States.

What clinical trials is Moexipril/hydrochlorothiazide 15 in?

Moexipril/hydrochlorothiazide 15 has two completed Phase 1 trials. NCT00834067 evaluated the drug under non-fasting conditions, and NCT00835042 evaluated it under fasting conditions. Each trial enrolled 60 healthy adults aged 18 years and older in the United States.

Is Moexipril/hydrochlorothiazide 15 the same as moexipril and hydrochlorothiazide?

Moexipril/hydrochlorothiazide 15 is a combination product that contains moexipril and hydrochlorothiazide. It is being studied as a fixed-dose tablet, with the trials specifically testing the 15/25 mg strength. The drug is in Phase 1 development for healthy volunteers.