An Open Label, Randomized, 2-Sequence, Multiple-Dose Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001058

Enrollment

Registered

2014-04-11

Start date

2014-05-15

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Sevikar®: amlodipine besylate/olmesartan medoxomil Crestor®: rosuvastatin calcium

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1.Healthy male subjects aged 19 - 55 years 2.A body mass index in the range 19 - 27 kg/m2 3.Willingness to participate during the entire study period 4.Written informed consent after being fully informed about the study procedures

Exclusion criteria

Exclusion criteria: 1.Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease 2.History of clinically significant drug hypersensitivity 3.Use of medication within 7 days before the first dose 4.Heavy drinker (>140 g/week) 5.Whole blood donation during 60 days before the study 6.Judged not eligible for study participation by investigator

Design outcomes

Secondary

Measure	Time frame
tss,max, Css,min	—

Primary

Measure	Time frame
AUCt, Css,max	—

Countries

Korea, Republic of

Contacts

Public ContactJungRyul Kim

Samsung Medical Center

Outcome results