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A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers

NCT05358756 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-05-26

No results posted yet for this study

Summary

This was a Phase 1, open-label, randomized, single center, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study between SACT-1 and Edurant® tablet.

Conditions

  • Healthy Subject

Interventions

DRUG

SACT-1

Single administartion of 150mg SACT-1

DRUG

EDURANT 25Mg Tablet

Single administartion of six EDURANT 25mg tablets (Total 150mg)

Sponsors & Collaborators

  • Aptorum International Limited

    lead INDUSTRY

Principal Investigators

  • Thomas Lee, PhD · Aptorum International Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-09
Primary Completion
2021-11-20
Completion
2021-12-14
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 NCT05358756 on ClinicalTrials.gov