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Clinical Trials/NL-OMON45490
NL-OMON45490
Withdrawn
Not Applicable

An open-label, randomized, crossover study to evaluate the pharmacokinetics, bioavailability, and bioequivalence following administration of JZP-507 oral solution and Xyrem®in healthy subjects. - JZP-507 PK, BA and BE study.

Jazz Pharmaceuticals0 sites60 target enrollmentTBD
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Conditionscataplexynarcolepsy10040998

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
cataplexy
Sponsor
Jazz Pharmaceuticals
Enrollment
60
Status
Withdrawn
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Healthy male or female volunteers
  • •18 \-45 years, inclusive
  • •BMI 20 \-30 kg/m2, inclusive
  • •Weight minimum 60 kilogram
  • •non smokers

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.

Outcomes

Primary Outcomes

Not specified

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