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A Study to Assess the Pharmacokinetics of Sorafenib in Mesoporous Magnesium Carbonate (DPH001) Compared to Nexavar® (sorafenib) in Healthy Volunteers

NCT06797427 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-03-17

No results posted yet for this study

Summary

The study aims to assess the pharmacokinetics and safety of DPH001, an amorphous formulation of sorafenib, compared to Nexavar® in healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

DPH001

100 mg

DRUG

Nexavar (Sorafenib)

200 mg

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Disruptive Pharma

    lead INDUSTRY

Principal Investigators

  • Björn Schultze, MD · Clinical Trial Consultants (CTC), Dag Hammarskjölds väg 10B, 752 37 Uppsala, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2025-03-10
Completion
2025-03-10

Countries

  • Sweden

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 NCT06797427 on ClinicalTrials.gov