At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 58 enrolled
Drug / intervention
TNP-2092 capsules +1 moredrug
Likely dose
TNP-2092 capsules 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TNP-2092 Capsules, and the Food Effect on the Pharmacokinetics of TNP-2092 Capsules After Single-dose Oral Administration in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating TNP-2092 capsules and TNP-2092 placebo capsules for Hyperammonemia. Completed, enrolled 58 participants across 1 site.
Detailed Summary
The aim of the study was to evaluate the tolerability and pharmacokinetic characteristics of TNP-2092 Capsules after single-dose administration in healthy subjects, and the food effect on pharmacokinetics.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperammonemia
CountriesChina
CollaboratorsThe First Hospital of Jilin University
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJun 2016
Primary CompletionAug 2016
First PostedDec 2023
TodayJul 2026
First PostedDec 21, 2023
Enrollment StartJun 6, 2016
Primary CompletionAug 2, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 2.5 years ago
Interventions
TNP-2092 capsulesdrug
Administered orally, 100 to 1200 mg
TNP-2092 placebo capsulesdrug
Administered orally