Status:
UNKNOWN
AK-R215 Pharmacokinetic Study Phase I
Lead Sponsor:
Alvogen Korea
Conditions:
Healthy
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215
Detailed Description
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the safety and pharmacokinetics characteristics after administration of fixed dose combination or loose combin...
Eligibility Criteria
Inclusion
- BW is above 50kg and BMI is between 18.5 and 30.0
- Subject who agreed and signed on informed consent form prior to the study participation
Exclusion
- Presence or history of clinically significant disease
- Treatment history of any drug which might affect IP within 10days
- History of other study drugs within 12weeks
Key Trial Info
Start Date :
July 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 12 2018
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03321318
Start Date
July 13 2017
End Date
January 12 2018
Last Update
October 25 2017
Active Locations (1)
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1
Dong-A University Hospital
Busan, South Korea