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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 administration

t1/2β 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

Page last updated: August 23, 2015

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