A SINGLE DOSE, RANDOMIZED, OPEN-LABEL, 4-WAY CROSSOVER STUDY TO ASSESS THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ESKETAMINE (ORAL TABLET OF 20 MG AND 100 MG, ORAL SOLUTION OF 20 MG AND IV INFUSION OF 20 MG) IN HEALTHY VOLUNTEERS.
Completed
- Conditions
- Depression.10027946
- Registration Number
- NL-OMON43097
- Lead Sponsor
- CIMA Labs, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
healthy male or female
18-55 years, inclusive
BMI 19.0 - 29.0 kg/m2, inclusive
at least 60 kg or more
non smoking
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* To evaluate the safety and tolerability after oral and intravenous (iv)<br /><br>administration of esketamine<br /><br>* To evaluate the pharmacokinetics (PK) of esketamine and its metabolites after<br /><br>oral and iv administration of esketamine<br /><br>* To assess the absolute bioavailability of esketamine after oral<br /><br>administration of esketamine<br /><br>* To assess the relative bioavailability of oral tablets with esketamine<br /><br>compared with an oral solution with esketamine<br /><br>* To assess the dose proportionality of esketamine and its metabolites after<br /><br>oral administration of 20 mg and 100 mg esketamine as oral tablets<br /><br>* To assess the parent to metabolite ratios after oral and iv administration of<br /><br>esketamine </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>