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

NCT02704702 | Completed Phase 1 Results

• 2 other identifiers: BR-FRC-CT-102CA16652
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertension

Keywords

Fimasartan

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-time Curve

  This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method

  For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period

• Maximum Observed Concentration

  This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.

  For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period

• Time to Reach Maximum Observed Plasma Concentration

  This Outcome is the time it takes a drug to reach Cmax

  For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period

Study Arms (6)

Sequence 1 (ABC)

OTHER

Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C) There will be a washout of at least 7 days between the each period.

Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin

Sequence 2 (ACB)

OTHER

Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period.

Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin

Sequence 3 (BAC)

OTHER

Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3) There will be a washout of at least 7 days between the each period.

Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin

Sequence 4 (BCA)

OTHER

Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period.

Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin

Sequence 5 (CAB)

OTHER

Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period.

Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin

Sequence 6 (CBA)

OTHER

Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period.

Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin

Interventions

Fimasartan DRUG

Sequence 1 (ABC); Sequence 2 (ACB); Sequence 3 (BAC); Sequence 4 (BCA); Sequence 5 (CAB); Sequence 6 (CBA)

Rosuvastatin DRUG

Sequence 1 (ABC); Sequence 2 (ACB); Sequence 3 (BAC); Sequence 4 (BCA); Sequence 5 (CAB); Sequence 6 (CBA)

Fimasartan + Rosuvastatin DRUG

Sequence 1 (ABC); Sequence 2 (ACB); Sequence 3 (BAC); Sequence 4 (BCA); Sequence 5 (CAB); Sequence 6 (CBA)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Several sampling time deviations occurred during the clinical conduct of this study. Actual sampling times relative to dosing time were used for caculation of PK parameters.

Results Point of Contact

• Title: Dr.Laura Sterling
• Organization: Celerion

laura.sterling@celerion.com

1-402-476-2811

Study Officials

• Laura Sterling, M.D

  Celelion, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 10, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-02