MedTrace Logo

Bupropion Stereoselective Disposition and CYP2D6-mediated Drug Interactions in Healthy Volunteers

NCT03420469 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-12-23

No results posted yet for this study

Summary

Primary objectives:

1. To comprehensively characterize steady state stereoselective pharmacokinetics of bupropion and its primary and secondary metabolites in healthy volunteers
2. To prospectively determine the time course (onset), extent and offset of CYP2D6 inhibition in relation to the pharmacokinetic profiles of bupropion and metabolites.

Conditions

  • Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis)

Interventions

DRUG

Bupropion

Phase 1: Baseline CYP2D6 activity, using dextromethorphan (30 mg single dose PO) as a probe drug Phase 2: Single dose bupropion pharmacokinetics and its effect on CYP2D6 activity (determined by dextromethorphan 30 mg single dose PO) Phase 3: Steady state disposition of bupropion and its interaction with CYP2D6 activity (30 mg single dose PO)

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Indiana University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2019-05-01
Completion
2019-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03420469 on ClinicalTrials.gov