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Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers

NCT05983328 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-08-09

No results posted yet for this study

Summary

Fasting Period: At least 10 hours prior to dosing until 4 hours post-dose of each study period.

Period: 24 hours post dose in each period. Each subject will complete two study periods.

Washout Period: At least one week after dosing of the previous period.

Confinement: From at least 10 hours prior to dosing until at least 12 hours post-dose, for a total of at least 22 hours for each study period.

Conditions

Interventions

DRUG

HUYPS-1 one tablet

After 7-day washout time, subjects will receive HUYPS-1 1 tablet.

DRUG

HUYPS-1 nine tablets

After 7-day washout time, subjects will receive HUYPS-1 9 tablets.

Sponsors & Collaborators

  • Sinew Pharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-05-10
Primary Completion
2016-05-26
Completion
2018-02-09

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT05983328 on ClinicalTrials.gov