Phase 1 Completed N=36 Randomized Other

A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects

Hypertension

Source: ClinicalTrials.gov NCT02704702 ↗

Enrolled (actual)

Serious AEs

0.5%

Results posted

Nov 2018

Primary outcomePrimary: Area Under the Concentration-time Curve — 690.43; 820.86; 86.442; 114.55 ng*hr/mL

Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Concentration-time Curve	690.43; 820.86; 86.442; 114.55; 702.20; 85.078	—
PRIMARY Maximum Observed Concentration	289.12; 362.14; 9.305; 11.706; 283.73; 341.92	—
PRIMARY Time to Reach Maximum Observed Plasma Concentration	0.749; 0.635; 2.999; 4.505; 0.750; 0.751	—

Eligibility Criteria

Inclusion Criteria

Caucasian male 19-55 years of age.
Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
Medically healthy with no clinically significant medical history.
Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria

History or presence of clinically significant medical or psychiatric condition or disease.
Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
Plasma donation within 7 days prior to the first dose of study drug.
Participation in another clinical trial within 28 days prior to the first dose of study drug(s).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02704702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.