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Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates

NCT06930872 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-02-09

No results posted yet for this study

Summary

This study is an open-label drug-drug interaction (DDI) study of ZYN002 transdermal gel and multiple drugs.

Conditions

  • Drug Interaction

Interventions

DRUG

Part 1

ZYN002 (transdermal), midazolam (oral), omeprazole (oral), losartan (oral), dextromethorphan (oral), caffeine (oral), repaglinide (oral), bupropion (oral)

DRUG

Part 2

ZYN002 (transdermal), VPA (oral)

Sponsors & Collaborators

  • Harmony Biosciences Management, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Polasek, MD, PhD · CMAX Clinical Research

  • Kristen Bzdek, MD · Harmony Biosciences Management, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-06-06
Primary Completion
2025-10-04
Completion
2025-11-04

Countries

  • Australia

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 NCT06930872 on ClinicalTrials.gov