Trials / Completed
CompletedNCT04300621
A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants
An Open-label, Randomized, Four-way Crossover, Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-06-19
- Primary completion
- 2020-08-10
- Completion
- 2020-08-10
- First posted
- 2020-03-09
- Last updated
- 2025-04-27
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04300621. Inclusion in this directory is not an endorsement.