Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease

Recruiting Phase 1 Interventional Study
Cholestatic Liver Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
6 (estimated)
Sponsor
Zydus Therapeutics Inc. · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: 1. Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF. 2. Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening. 3. Ability to swallow and retain oral medication. 4. Subjects having documented history of hepatic impairme…
Contacts

Farheen Shaikh

+1-609-453-4751

fshaikh@zydustherapeutics.com

CONTACT

Deven Parmar

+1-609-946-9340

dparmar@zydustherapeutics.com

CONTACT