Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT05847218
Brief Summary:
The goal of this clinical Trial is to assess the safety, tolerability and Pharmacokinetic profile of 750 mg single oral dose of RHN-001 and 1500 mg of RHN-001 administered orally in fasted and fed conditions in healthy adult volunteers.
Detailed Description:
The study is planned to be conducted in Two Phases (Cohort A and Cohort B). The first phase will be carried out in two Cohorts i.e., a single oral dose of investigational drug 750 mg or placebo under fasting (Cohort A1) and a single oral dose of investigational drug 750 mg or placebo under fed conditions (Cohort A2).
The second phase of the study will also be carried out in two cohorts i.e., a single oral dose of 1500 mg or placebo under fasting (Cohort B1) and a single oral dose of 1500 mg or placebo under fed conditions (Cohort B2).
Blood samples will be obtained from the volunteers at different time-points i.e. 0.0 hour (before dosing), 15.0 minutes, 30.0 minutes, 1.0 hour, 2.0, 3.0, 4.0, 8.0, 12.0 and 24.0 hours post-dose in each cohort.
Urine samples (10 mL) for PK analysis will be collected after dosing for 24 hours whenever the subjects feel to urinate during their stay at the clinical trial site.
Study:
NCT05847218
Study Brief:
Protocol Section:
NCT05847218