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Completed

NCT Number: NCT01289886

Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects

The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic (PK/PD) of ascending single oral dose of BR-A-657 in healthy male subjects.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

BR-A-657 20, 50, 120, 240, 360, 480mg or placebo were administered once to healthy male subjects.

Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times from each subjects.

PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone, Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male of 18-55 years old
  • Body Mass Index(BMI) 19-29kg/m2
  • subjects in good health
  • subjects with written informed consent

Exclusion criteria

  • subjects with multiple drug allergy or allergy to Angiotensin Receptor Blocker(ARB)
  • subjects with medication that affect drug absorption or elimination within 30days.
  • subjects with orthostatic hypotension of >20mmHg decrease of Systolic Blood Pressure(SBP)
  • subjects with history of neurologic, liver, renal, gastrointestinal, cardiovascular, psychological or other major disorder

Treatment and study plan

BR-A-657

Drug

20, 60, 120, 240, 360, 480mg or placebo tablet

Other names: Fimasartan, 20, 60, 120, 240, 360, 480mg

Primary outcomes

  1. No of subjects with Adverse events(AE) from each observations

    Time frame: up to 5~7days post-dose

    • AE reporting: Pre dose, 3, 12, 24h, (48 h: Groups C, D, E) post dose
    • Vital signs: Pre dose*, 0.5, 1*, 2, 4*, 6, 8*, 12 and 24* h post dose (*:both supine and standing)
    • ECG: Pre dose, 2, 4, 8 and 24 h post dose
    • Clinical laboratory examination: Pre dose and 24 h post dose
    • Physical examination: predose, 5~7days post dose
    • Body weight: predose, 5~7days post dose

Secondary outcomes

  1. Area under the plasma concentration time curve (AUC)

    Time frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h

  2. Maximum observed plasma concentration (Cmax)

    Time frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h

  3. Time of the maximum observed plasma concentration (Tmax)

    Time frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h

  4. Apparent total plasma clearance (CL/F)

    Time frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h

  5. Apparent plasma terminal elimination half life (t½)

    Time frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Collaborators

  • Covance

Registry information

Official study title

BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Single Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects Incorporating a Comparison of Fed/Fasted Pharmacokinetics

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Feb 4, 2011
Registry last updated
Feb 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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