Evaluating a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin

An Open-label, Randomized, Single-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin in Healthy Male Volunteers

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02140489

Enrollment

Registered

2014-05-16

Start date

2014-02-28

Completion date

2014-08-31

Last updated

2014-05-16

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

Conditions

Healthy

Brief summary

The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers.

Interventions

DRUGamosartan

DRUGrosuvastatin

DRUGamosartan and rosuvastatin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male * Age between 19 and 55 * Signed informed consent

Exclusion criteria

* Presence of medical history or a concurrent disease * Has a history of hypersensitivity to IP ingredients

Design outcomes

Primary

Measure	Time frame
Cmax	0-72h
AUClast	0-72h

Secondary

Measure	Time frame
tmax	0-72h
t1/2	0-72h
AUCinf	0-72h

Countries

South Korea

Contacts

Primary ContactJin-A Jung, Ph.D

jajung@hanmi.co.kr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026