Recent Updates
Recently added Catalysts

Losartan/Hydrochlorothiazide

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as Losartan

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials4
Total Enrollment260

FDA Designations

No designations recorded

Clinical trial landscape

Losartan/Hydrochlorothiazide · 4 trials · 1 indication

Phase 1 4
NCT01149473Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting ConditionsHealthy
COMPLETED80 Analytics
NCT01149486Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting ConditionsHealthy
COMPLETED20 Analytics
NCT01124162Losartan 100 mg Tablets in Healthy Subjects Under Fasting ConditionsHealthy
COMPLETED80 Analytics
NCT01124175Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting ConditionsHealthy
COMPLETED80 Analytics
PHASE1COMPLETED
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions
Healthy
NCT0114947380
Unlock trial analytics
PHASE1COMPLETED
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions
Healthy
NCT0114948620
Unlock trial analytics
PHASE1COMPLETED
Losartan 100 mg Tablets in Healthy Subjects Under Fasting Conditions
Healthy
NCT0112416280
Unlock trial analytics
PHASE1COMPLETED
Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions
Healthy
NCT0112417580
Unlock trial analytics

Study Endpoints

Primary Endpoints

Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 48 hour period.

Bioequivalence based on Losartan Cmax.

AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 48 hour period.

Bioequivalence based on Losartan AUC0-t.

AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 48 hour period.

Bioequivalence based on Losartan AUC0-inf.

Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 48 hour period.

Bioequivalence based on Hydrochlorothiazide Cmax.

AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 48 hour period.

Bioequivalence based on Hydrochlorothiazide AUC0-t.

AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 48 hour period.

Bioequivalence based on Hydrochlorothiazide AUC0-inf.

Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 48 hour period.

Bioequivalence based on Hydrochlorothiazide Cmax.

Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 24 hour period.

Bioequivalence based on Losartan Cmax.

AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 24 hour period.

Bioequivalence based on Losartan AUC0-t.

AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 24 hour period.

Bioequivalence based on Losartan AUC0-inf.

Secondary Endpoints

Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 48 hour period.
AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 48 hour period.
AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 48 hour period.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Generic Test ProductEXPERIMENTALLosartan potassium/Hydrochlorothiazide 100/25 mg Tablets
Reference Listed DrugACTIVE_COMPARATORHyzaar® 100/25 mg Tablets

Interventions

NameTypeDescription
Losartan potassium/HydrochlorothiazideDRUG100/25 mg Tablets
Hyzaar®DRUG100/25 mg Tablets
LosartanDRUG100 mg Tablet
Cozaar®DRUG100 mg Tablet
Unlock Study Design Details

Eligibility Criteria

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

Inclusion Criteria: * Healthy, non-smoking, male and female subjects at least 18 years of age. * BMI (body mass index) of 30 or less. * Females in this study must be physically unable to become pregnant (postmenopausal for at least 6 months or surgically sterile). * Successful completion of a physi...

Countries:United StatesCanada
Unlock Eligibility Criteria