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A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants

NCT04300621 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-04-27

No results posted yet for this study

Summary

The purpose of the study in healthy participants is to characterize the plasma pharmacokinetic (PK) profile of different single dose Oral Thin Film (OTF) (S)-ketamine formulations administered sublingually.

Conditions

  • Healthy

Interventions

DRUG

OTF 1

Participants will receive (S)-ketamine administered sublingually through OTF 1.

DRUG

OTF 2

Participants will receive (S)-ketamine administered sublingually through OTF 2.

DRUG

OTF 3

Participants will receive (S)-ketamine administered sublingually through OTF 3.

DRUG

OTF 4

Participants will receive (S)-ketamine administered sublingually through OTF 4.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2020-08-10
Completion
2020-08-10

Countries

  • Belgium

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 NCT04300621 on ClinicalTrials.gov