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Label indication Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. FDA label
Hydrochlorothiazide · 1 trial · 1 indication
Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)
| Arm | Type | Description |
|---|---|---|
| Sotagliflozin + Hydrochlorothiazide (HCTZ) | EXPERIMENTAL | Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days. |
| Name | Type | Description |
|---|---|---|
| Sotagliflozin (SAR439954) | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| Hydrochlorothiazide | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
Inclusion criteria : * Male or female subjects, between 18 and 55 years of age, inclusive. * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive. * Certified as healthy by a comprehensi...
Hydrochlorothiazide is being studied in a Phase 1 drug interaction trial in Type 2 Diabetes Mellitus. The completed study evaluated co-administration with sotagliflozin in 16 healthy adult volunteers in the United States. Hydrochlorothiazide is a small molecule developed by Sanofi.
Hydrochlorothiazide targets SLC12A3 and acts as an inhibitor of this target. SLC12A3 is the sodium chloride cotransporter. This mechanism underlies the drug's pharmacological activity as a small molecule therapeutic.
Hydrochlorothiazide is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor associated with the clinical development of this small molecule asset.
Hydrochlorothiazide is in Phase 1 clinical development for Type 2 Diabetes Mellitus. It is investigational and has not been approved for this indication. The single Phase 1 trial has been completed.
Hydrochlorothiazide was evaluated in one completed Phase 1 trial, NCT03387657, titled A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide. The study enrolled 16 healthy adult volunteers in the United States and assessed the interaction between sotagliflozin and Hydrochlorothiazide.