A Pharmacokinetic Study of Budesonide Delayed Release Tablet D23A (D23) in Healthy Chinese Participants Under Fasting Conditions
NCT07925216, Phase 1, Active not recruiting, Triastek, lnc.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Pharmacokinetic Study of Budesonide Delayed Release Tablet D23A (D23) in Healthy Chinese Participants Under Fasting Conditions | ClinicalTrials.gov |
| NCT number | NCT07925216 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 18 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Triastek, lnc. | ClinicalTrials.gov |
| Conditions | IgA Nephropathy (IgAN) | ClinicalTrials.gov |
| Interventions | Budesonide delayed release tablet 4mg, Budesonide Delayed Release Capsules, Budesonide delayed release tablet 16mg | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cmax | up to 48 hours post-dose | Primary PK parameters | ClinicalTrials.gov |
| Primary | AUC4-t | up to 48 hours post-dose | Primary PK parameters | ClinicalTrials.gov |
| Primary | AUC0-t | up to 48 hours post-dose | Primary PK parameters | ClinicalTrials.gov |
| Primary | AUC0-∞ | up to 48 hours post-dose | Primary PK parameters | ClinicalTrials.gov |
| Primary | Tmax | up to 48 hours post-dose | Secondary PK parameters | ClinicalTrials.gov |
| Primary | Tlag | up to 48 hours post-dose | Secondary PK parameters | ClinicalTrials.gov |
| Primary | AUC0-4 | up to 4 hours post-dose | Secondary PK parameters | ClinicalTrials.gov |
| Primary | t1/2 | up to 48 hours post-dose | Secondary PK parameters | ClinicalTrials.gov |
| Primary | λz | up to 48 hours post-dose | Secondary PK parameters | ClinicalTrials.gov |
| Primary | AUC %Extrap | up to 48 hours post-dose | Secondary PK parameters | ClinicalTrials.gov |
| Primary | CL/F | up to 48 hours post-dose | Secondary PK parameters | ClinicalTrials.gov |
| Primary | VZ/F | up to 48 hours post-dose | Secondary PK parameters | ClinicalTrials.gov |
| Secondary | Incidence of adverse events (AEs) | Through study completion, an average of 13 days | 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)