The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02387619

Enrollment

Registered

2015-03-13

Start date

2015-02-28

Completion date

2015-07-31

Last updated

2016-06-24

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

Conditions

Hyperlipidemia, Hypertension

Brief summary

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

Detailed description

A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

Interventions

DRUGRosuvastatin

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days

DRUGTelmisartan/Amlodipine

Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days

DRUGRosuvastatin and Telmisartan/Amlodipine

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days

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

* 19\ 55 years healthy male * Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2 * Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion criteria

* Subjects who are allergic to investigational drug. * Subjects who have a medical history which can affect the clinical trial. * Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg) * Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

Design outcomes

Primary

Measure	Time frame
AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine	72hours, 144hours

Secondary

Measure	Time frame
AUCinf,ss of Rosuvastatin	72hours
Tmax,ss of Rosuvastatin	72hours
t1/2 of Rosuvastatin	72hours
AUClast,ss of Rosuvastatin	72hours
AUCinf,ss of Telmisartan, Amlodipine	144hours
Tmax,ss of Telmisartan, Amlodipine	144hours
t1/2 of Telmisartan, Amlodipine	144hours
AUClast,ss of Telmisartan, Amlodipine	144hours

Countries

South Korea

Outcome results

None listed

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