Supplementary file 1_Pharmacokinetics, safety, and population pharmacokinetic profiles of

A Phase I clinical trial in China evaluated the pharmacokinetics and safety of Ritanine (HR20013), a fixed-dose combination drug, in subjects with moderate hepatic impairment versus healthy controls. The dataset includes results from a nonrandomized, open-label, single-dose study involving eight subjects per group, with pharmacokinetic parameters such as Cmax, AUC, Tmax, and elimination half-life. The study was conducted by Qingmei Li and registered under CTR20233771.

Use Cases

• Compare pharmacokinetic parameters (Cmax, AUC) between healthy and hepatically impaired subjects based on the described trial results.
• Assess the safety and tolerability of a fixed-dose combination drug in a specific patient population based on the study's conclusion.
• Model population pharmacokinetic profiles for rolapitant and its metabolites using the geometric mean ratios provided.
• Investigate the impact of hepatic impairment on drug elimination half-life (t1/2) and time to maximum concentration (Tmax).

Strengths

• Includes pharmacokinetic data for multiple analytes: fosrolapitant, rolapitant, metabolite M19, and palonosetron.
• Provides specific geometric least-squares mean ratios for key PK parameters (e.g., 1.51 for fosrolapitant AUC).
• Compares two distinct cohorts: eight subjects with moderate hepatic impairment and eight healthy controls.

Limitations

• Row count is unknown, which may limit suitability assessment.
• Column-level documentation is absent; field semantics must be inferred after download.
• The dataset is small in scale (438.8 KB), indicating limited data volume.

Provenance

Source

figshare

Collection Method

Data likely originates from a nonrandomized, open-label, single-dose Phase I clinical trial.

Freshness

Last updated 2026-06-01 07:58:12; freshness should be verified.

Geography

China