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Hydrochlorothiazide

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Apr 25, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Hydrochlorothiazide · 1 trial · 1 indication

Phase 1 1
NCT03387657A Drug to Drug Interaction Study of Sotagliflozin With HydrochlorothiazideType 2 Diabetes Mellitus
COMPLETED16 Analytics
PHASE1COMPLETED
A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of PK parameter: AUCtau
Period 1, days 2 to 6

Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)

Secondary Endpoints

Assessment of PK parameter: AUCtau
Period 2, days 4 to 5
Assessment of PK parameter: Cmax
Period 2, days 4 to 5
Assessment of PK parameter: tmax
Period 2, days 4 to 5
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sotagliflozin + Hydrochlorothiazide (HCTZ)EXPERIMENTALSotagliflozin 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.

Interventions

NameTypeDescription
Sotagliflozin (SAR439954)DRUGPharmaceutical form: Tablet Route of administration: Oral
HydrochlorothiazideDRUGPharmaceutical form: Tablet Route of administration: Oral
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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