Pharmacokinetic Study of Livalo� Fixed Combination Drug in Healthy Subjects
Information source: JW Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia; Hypertension
Intervention: Livalo fixed combination drug (Drug); Pitavastatin, Valsartan (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: JW Pharmaceutical Official(s) and/or principal investigator(s):
Kyun Seop Bae, MD, Principal Investigator, Affiliation: Asan Medical Center
Summary
The purpose of this study is to compare pharmacokinetics between Pitavastatin and Valsartan
co-administration and Livalo fixed combination drug in healthy male subjects.
Clinical Details
Official title: A Single Dose, Sequence-randomized, Open-label, 2x2 Crossover Study to Compare Pharmacokinetics Between Pitavastatn and Valsartan Co-administration and Livalo Complex Product in Healthy Male Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Cmax and AUC of study drugs after single oral administration
Secondary outcome: AUCinf of study drugs after single oral administrationt1/2β of study drugs after single oral administration Tmax of study drugs after single oral administration
Eligibility
Minimum age: 20 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Healthy male volunteers
- Age 20-55 years at the time of Screening
- BMI 19-26 kg/m2 at the time of Screening
Exclusion Criteria:
- Received other investigational drug within 90 days prior to the first dose of study
drug
Locations and Contacts
Asan Medical Center, Seoul 138-736, Korea, Republic of; Not yet recruiting
Shihyang Lee, Phone: +82-2-3010-6052, Email: phase1@amc.seoul.kr
Additional Information
Starting date: January 2013
Last updated: January 7, 2013
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