carenoprazan (H008) / Carephar Pharma - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008 (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Jiangsu Carephar Pharmaceutical Co., Ltd. | Enrolling by invitation ➔ Completed

Trial completion • Gastrointestinal Disorder

THE EFFICACY AND SAFETY OF KEVERPRAZAN (H008) IN THE TREATMENT OF DUODENAL ULCER: A MULTICENTERED, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROL TRIAL IN CHINA (UEGW 2022) - "Keverprazan 20 mg was not inferior to lansoprazole 30 mg once daily for healing of DU with a good safety profile."

Clinical • Peptic Ulcer

Fertility and early embryonic development toxicity and toxicokinetic study of KFP-H008 in Sprague-Dawley rats. (PubMed, Birth Defects Res) - "Overall, the NOAEL of KFP-H008 was considered to be 45 mg/kg in both genders and the TK study shows that exposure (area under the curve) of male rats was about 1,091.0 ± 530.8 μg/Lhr and to female rats was 1,030.5 ± 512.5 μg/Lhr. Administration of KFP-H008although reaches the reproductive organs, it demonstrated no significant effects on reproductive organs, it did not affect mating, fertility, pregnancy, growth, or morphologic development."

Journal • Preclinical