NCT01369472

Brief Summary

This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

April 21, 2011

Last Update Submit

February 13, 2012

Conditions

Chronic Stable Angina

Outcome Measures

Primary Outcomes (5)

  • Dose-proportionality

    AUClast

    0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h

  • Dose-proportionality

    AUC0-∞

    0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h

  • Dose-proportionality

    Cmax

    0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h

  • Dose-proportionality

    Tmax

    0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h

  • Dose-proportionality

    t½β

    0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h

Secondary Outcomes (1)

  • Safety

    0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d)

Study Arms (5)

Dilatrend SR capsule 8mg

EXPERIMENTAL
Drug: Dilatrend SR capsule

Dilatrend SR capsule 16mg

EXPERIMENTAL
Drug: Dilatrend SR capsule

Dilatrend SR capsule 32mg

EXPERIMENTAL
Drug: Dilatrend SR capsule

Dilatrend SR capsule 64mg

EXPERIMENTAL
Drug: Dilatrend SR capsule

Dilatrend SR capsule 128mg

EXPERIMENTAL
Drug: Dilatrend SR capsule

Interventions

Dilatrend SR capsuleDRUG

single oral administration in period 1 or 2, 3 for each sequential group.

Dilatrend SR capsule 128mgDilatrend SR capsule 16mgDilatrend SR capsule 32mgDilatrend SR capsule 64mgDilatrend SR capsule 8mg

Eligibility Criteria

Age20 Years - 54 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range 20 to 54 years, Body mass index of ≥19 and ≤26 healthy male volunteers
  • Able to participate in all procedure
  • SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 55-95 times/min
  • Have given written informed consent

You may not qualify if:

  • Have history of significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, musculoskeletal neurologic disease
  • Have history of gastrointestinal disease(Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia)
  • Have allergy or hypersensitivity to carvedilol or any component of the formulation(aspirin, antibiotics)
  • Have history of drug abuse. A positive test for any drug(amphetamine, barbiturates, cocaine, opiates, benzodiazepines, THC, methadone, ect.) included in the urine drug screen.
  • Have herbal drug within 30days prior to the first IP administration, have ETC within 14days prior to the first IP administration, have OTC 7days prior to the first IP administration.
  • Have diet which may influence on the absorption, distribution, metabolism or excretion of drug(s), (Drinking over 1L of grapefruit juice within 7days prior to the first IP administration)
  • Have received an investigational drug within 60 days prior to the first IP administration
  • Have donated whole blood within 60 days prior or donation plasma within 30 days prior to the first IP administration
  • Have any metabolic enzyme including or inhibiting drugs like barbiturates within 30 days prior to the first IP administration.
  • A heavy caffeine/alcohol consumer or a heavy smoker(caffeine \> 5 units/days. alcohol \>21 units/week (1 unit=pure alcohol 10mL), Cigarette \> 10 Cigarettes/day) or alcohol abuse.
  • Positive for Hepatitis B, Hepatitis C, HIV or syphilis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medcial Center

Songpa-gu, Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • KS Bae, Ph.D

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2011

First Posted

June 9, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations

KR(1)