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Completed

NCT Number: NCT01289899

Fimasartan (BR-A-657) Multiple 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 multiple 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-657 120, 360, or placebo were administered once daily for 7days to 16 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
  • BMI 19-29kg/m2
  • subjects in good health
  • subjects with written informed consent

Exclusion criteria

  • subjects with multiple drug allergy or allergy to ARB
  • subjects with medication that affect drug absorption or elimination within 30days.
  • subjects with orthostatic hypotension of >20mmHg decrease of sbp
  • subjects with history of neurologic, liver, renal, GI, CV, psychological or other major disorder

Treatment and study plan

BR-A-657

Drug

120, 360mg or placebo 7days

Other names: Fimasartan

Primary outcomes

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

    Time frame: up to 5~7days post final(7th) dose

    • AE reporting: Day 1: Predose, 3 & 12h, Days 2~7: Predose, Days 8,9: Once daily, 5~7days post final dose
    • Vital signs: Day 1: Predose, 0.5,1,2,4,8,12,24h,Days 3~6: Predose Day 7: Predose, 0.5,1,2,4,8,12,24,48h, 5~7days post final dose
    • ECG: Days 1 & 7: Predose, 2, 4, 8 & 24h, Day 4: Predose, 5~7days post final dose
    • Laboratory examination: Days 1 & 4: Predose, Day 7: Predose & 24h, 5~7days post final dose
    • Physical examination: predose, 5~7days post final dose
    • Body weight: predose, Days 4 & 8

Secondary outcomes

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

    Time frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7

  2. Maximum observed plasma concentration (Cmax).

    Time frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7

  3. parent plasma terminal elimination half life (t½)

    Time frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7

  4. Apparent total plasma clearance (CL/F)

    Time frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7

  5. Accumulation ratio (RA)

    Time frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7

    RA1=Accumulation ratio based on AUCinf

    RA2=Accumulation ratio based on Cmax

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 Multiple Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
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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