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Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms

NCT06062810 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-04-23

No results posted yet for this study

Summary

Explore the relationship between drug target ER gene single nucleotide polymorphisms and Raloxifene therapeutic effects in patients with Breast Cancer LCIS, based on Oxford precisely sequencing drug targets' genes.

Explore the relationship between drug target UGT gene single nucleotide polymorphisms and Raloxifene side-effects in patients with Breast Cancer LCIS, based on Oxford precisely sequencing drug targets' genes.

Conditions

Interventions

DRUG

Raloxifene - Usual

* Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg x 2 taken orally daily

DRUG

Raloxifene - Study

* Generic-2 - Raloxifene Hydrochloride Tablet * Raloxifene 60 mg x 2 taken orally daily

Sponsors & Collaborators

  • Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

    lead INDUSTRY

Principal Investigators

  • Han Xu, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

  • Han Xu, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

  • Han Xu, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-21
Primary Completion
2026-12-18
Completion
2026-12-28
FDA Drug
Yes

Countries

  • United States

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 NCT06062810 on ClinicalTrials.gov