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NCT06107205 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects
A Phase 1 study of Healthy Adult Subjects, sponsored by Shanghai Auzone Biological Technology Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT06107205: Completed Phase 1 study of Healthy Adult Subjects, sponsored by Shanghai Auzone Biological Technology Co..
NCT06107205 is a Phase 1 study of Healthy Adult Subjects that has completed, run by Shanghai Auzone Biological Technology Co.. The registered enrollment target is 29 participants, below the 34-participant average among 3 other Healthy Adult Subjects trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06107205, a Phase 1 study of Healthy Adult Subjects, has completed, sponsored by Shanghai Auzone Biological Technology Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions.The objective is To characterize the bioequivalence、safety and tolerability of TTYP01 tablets and Radicava® injection or Radicava ORS®in healthy adult subjects under fasted conditions.In this study, 30 healthy adult subjects will receive TTYP01, or Radicava, orRadicava ORS in each period according to the randomization sequence.
Conditions Studied
Interventions
- DRUG TTYP01
- DRUG Radicava
- DRUG Radicava ORS
Study Locations (1)
Texas
- ICON Early Phase Services - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2023-11-07 |
| Est. Completion | 2023-12-14 |
| Phase | Phase 1 |
What the finished NCT06107205 record still lists
NCT06107205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 34-participant average among 3 other Healthy Adult Subjects trials with a reported enrollment target (15% lower).
The record links to 1 condition, with Healthy Adult Subjects appearing as the primary indexed condition, and to 3 interventions - of which TTYP01 is the first listed.
NCT06107205 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06107205 about?
NCT06107205 is a clinical study titled "Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects". This is a Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions.The objective is To characterize the bioequivalence、safety and t...
What is the current status of trial NCT06107205?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2023-11-07. Estimated completion is 2023-12-14.
What conditions does trial NCT06107205 study?
This clinical trial studies the following conditions: Healthy Adult Subjects.
What interventions are being tested in trial NCT06107205?
The interventions under investigation include: TTYP01 (DRUG), Radicava (DRUG), Radicava ORS (DRUG).
Who is sponsoring clinical trial NCT06107205?
This trial is sponsored by Shanghai Auzone Biological Technology Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06107205 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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