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Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects

NCT06107205 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-04-24

No results posted yet for this 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

  • Healthy Adult Subjects

Interventions

DRUG

TTYP01

1 single oral dose of 90 mg TTYP01 (3 tablets of the test drugs, test formulation T)

DRUG

Radicava

1 injection of 60 mg Radicava (reference drug R1, intravenous infusion of 60 mg administered over 60 minutes)

DRUG

Radicava ORS

1 single oral dose of 105 mg/5 mL Radicava ORS (reference drug R2)

Sponsors & Collaborators

  • Shanghai Auzone Biological Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Robert. Bass, MD · ICON plc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2023-12-14
Completion
2023-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06107205 on ClinicalTrials.gov