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Also known as Losartan
Losartan/Hydrochlorothiazide · 4 trials · 1 indication
Bioequivalence based on Losartan Cmax.
Bioequivalence based on Losartan AUC0-t.
Bioequivalence based on Losartan AUC0-inf.
Bioequivalence based on Hydrochlorothiazide Cmax.
Bioequivalence based on Hydrochlorothiazide AUC0-t.
Bioequivalence based on Hydrochlorothiazide AUC0-inf.
Bioequivalence based on Hydrochlorothiazide Cmax.
Bioequivalence based on Losartan Cmax.
Bioequivalence based on Losartan AUC0-t.
Bioequivalence based on Losartan AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| Generic Test Product | EXPERIMENTAL | Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets |
| Reference Listed Drug | ACTIVE_COMPARATOR | Hyzaar® 100/25 mg Tablets |
| Name | Type | Description |
|---|---|---|
| Losartan potassium/Hydrochlorothiazide | DRUG | 100/25 mg Tablets |
| Hyzaar® | DRUG | 100/25 mg Tablets |
| Losartan | DRUG | 100 mg Tablet |
| Cozaar® | DRUG | 100 mg Tablet |
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...
Losartan/Hydrochlorothiazide is a small molecule combination product developed by Teva Pharmaceutical Industries Limited (ticker TEVA). It combines losartan potassium with hydrochlorothiazide and has been studied in Phase 1 clinical trials. The program's specific therapeutic indications are undisclosed, and all four recorded trials have been completed.
Losartan/Hydrochlorothiazide targets AGTR1, the angiotensin II receptor type 1. Losartan acts as an antagonist at this receptor, and the product also contains hydrochlorothiazide. This mechanism information comes from the drug's molecular target and target class data, which identify AGTR1 antagonism as the relevant pharmacology for the combination.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of Losartan/Hydrochlorothiazide. Teva is listed as the sponsor of the clinical program for this combination product, which pairs losartan potassium with hydrochlorothiazide in a small molecule formulation.
Losartan/Hydrochlorothiazide is in Phase 1 development. All four registered trials for this product are Phase 1 studies, and all four have completed, with no active trials currently listed. The program has enrolled a total of 260 participants across its completed studies.
Four completed Phase 1 trials are registered for Losartan/Hydrochlorothiazide: NCT01149486 and NCT01149473 tested losartan potassium/hydrochlorothiazide 100/25 mg tablets in healthy subjects under fasting and non-fasting conditions, while NCT01124175 and NCT01124162 tested losartan 100 mg tablets in healthy subjects in Canada.
Losartan/Hydrochlorothiazide is also known as losartan potassium/hydrochlorothiazide, and it is sometimes searched simply as losartan. The combination product contains losartan potassium together with hydrochlorothiazide, so it is not identical to losartan alone. Two of its trials, NCT01124175 and NCT01124162, studied losartan 100 mg tablets by themselves.