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Clinical Trials/NL-OMON41817
NL-OMON41817
Completed
Not Applicable

An open-label, randomized crossover study to evaluate the pharmacokinetics, bioavailability, bioequivalence, and food effect following administration of Oxybate Formulations in healthy subjects. - JZP-258 Oxybate BA and FE study.

Jazz Pharmaceuticals0 sites60 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Jazz Pharmaceuticals
Enrollment
60
Status
Completed
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 18\-30 kg/m2, inclusive
  • •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.

Outcomes

Primary Outcomes

Not specified

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