A Phase I Study to Evaluate the Effect of Food on the Pharmacokinetics of HS-10382 Tablets in Healthy Participants
NCT07933224, Phase 1, Not yet recruiting, Jiangsu Hansoh Pharmaceutical Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Phase I Study to Evaluate the Effect of Food on the Pharmacokinetics of HS-10382 Tablets in Healthy Participants | ClinicalTrials.gov |
| NCT number | NCT07933224 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 32 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. | ClinicalTrials.gov |
| Conditions | Healthy Volunteers | ClinicalTrials.gov |
| Interventions | HS-10382 | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Evaluation of PK parameters of HS-10382: Cmax | 96 hours after administration of HS-10382 | To evaluate the Cmax of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Primary | Evaluation of PK parameters of HS-10382: AUC0-t | 96 hours after administration of HS-10382 | To evaluate the AUC0-t of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Primary | Evaluation of PK parameters of HS-10382: AUC0-∞ | 96 hours after administration of HS-10382 | To evaluate the AUC0-∞ of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | Evaluation of PK parameters of HS-10382: Tmax | 96 hours after administration of HS-10382 | To evaluate the Tmax of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | Evaluation of PK parameters of HS-10382: tlag | 96 hours after administration of HS-10382 | To evaluate the tlag of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | Evaluation of PK parameters of HS-10382: t1/2z | 96 hours after administration of HS-10382 | To evaluate the t1/2z of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | Evaluation of PK parameters of HS-10382: λz | 96 hours after administration of HS-10382 | To evaluate the λz of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | Evaluation of PK parameters of HS-10382: CL/F | 96 hours after administration of HS-10382 | To evaluate the CL/F of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | Evaluation of PK parameters of HS-10382: Vz/F | 96 hours after administration of HS-10382 | To evaluate the Vz/F of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | Evaluation of PK parameters of HS-10382: MRT | 96 hours after administration of HS-10382 | To evaluate the MRT of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | Adverse events | Up to end of the study, approximately 1 month. | To evaluate the vital signs of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | vital signs (blood pressure) | Up to end of the study, approximately 1 month | To evaluate the vital signs(blood pressure) of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | vital signs (Pulse) | Up to end of the study, approximately 1 month | To evaluate the vital signs(Pulse) of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | vital signs (body temperature) | Up to end of the study, approximately 1 month | To evaluate the vital signs(body temperature) of HS-10382 following fasting or fed administration | ClinicalTrials.gov |
| Secondary | clinical laboratory tests(complete blood count (CBC), urinalysis, blood chemistry, coagulation tests) | Up to end of the study, approximately 1 month | To evaluate the clinical laboratory tests (complete blood count (CBC), urinalysis, blood chemistry, coagulation tests) of HS-10382 following fasting or fed administration. | ClinicalTrials.gov |
| Secondary | 12-lead electrocardiogram (include heart rate, PR, RR, QRS duration and QTcF) | Up to end of the study, approximately 1 month | To evaluate the 12-lead electrocardiogram（include heart rate, PR, RR, QRS duration and QTcF） of HS-10382 following fasting or fed administration. | ClinicalTrials.gov |
| Secondary | physical examination of HS-10382 following fasting or fed administration | Up to end of the study, approximately 1 month | To evaluate the abnormal of the physical examination (general inspection, head and neck, lymph nodes, chest, abdomen, spine and extremities, and neurological examination) of HS-10382 following fasting or fed administration. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)