Clincosm LogoSign in Get a demo

Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT01369472
Collaborator
Asan Medical Center (Other)
30
Enrollment
1
Location
5
Arms
4
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Dilatrend SR capsule
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Single Dose, Dose-rising 10-sequence, 3-period Balanced Incomplete Blocked Clinical Trial to Evaluate Dose-proportionality of Dilatrend SR in Healthy Male Volunteers
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dilatrend SR capsule 8mg

Drug: Dilatrend SR capsule
single oral administration in period 1 or 2, 3 for each sequential group.
Experimental: Dilatrend SR capsule 16mg

Drug: Dilatrend SR capsule
single oral administration in period 1 or 2, 3 for each sequential group.
Experimental: Dilatrend SR capsule 32mg

Drug: Dilatrend SR capsule
single oral administration in period 1 or 2, 3 for each sequential group.
Experimental: Dilatrend SR capsule 64mg

Drug: Dilatrend SR capsule
single oral administration in period 1 or 2, 3 for each sequential group.
Experimental: Dilatrend SR capsule 128mg

Drug: Dilatrend SR capsule
single oral administration in period 1 or 2, 3 for each sequential group.

Outcome Measures

Primary Outcome Measures

  1. Dose-proportionality [0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h]

    AUClast

  2. Dose-proportionality [0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h]

    AUC0-∞

  3. Dose-proportionality [0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h]

    Cmax

  4. Dose-proportionality [0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h]

    Tmax

  5. Dose-proportionality [0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h]

    t½β

Secondary Outcome Measures

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

    Adverse Event/Serious Adverse Event monitoring Physical Examination, Vital Sign, 12-lead ECG, Lab Tests

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 54 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Age range 20 to 54 years, Body mass index of ≥19 and ≤26 healthy male volunteers

  2. Able to participate in all procedure

  3. SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 55-95 times/min

  4. Have given written informed consent

Exclusion Criteria:

  1. Have history of significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, musculoskeletal neurologic disease

  2. Have history of gastrointestinal disease(Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia)

  3. Have allergy or hypersensitivity to carvedilol or any component of the formulation(aspirin, antibiotics)

  4. 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.

  5. 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.

  6. 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)

  7. Have received an investigational drug within 60 days prior to the first IP administration

  8. Have donated whole blood within 60 days prior or donation plasma within 30 days prior to the first IP administration

  9. Have any metabolic enzyme including or inhibiting drugs like barbiturates within 30 days prior to the first IP administration.

  10. 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.

  1. Positive for Hepatitis B, Hepatitis C, HIV or syphilis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medcial Center Songpa-gu Seoul Korea, Republic of 138-736

Sponsors and Collaborators

  • Chong Kun Dang Pharmaceutical
  • Asan Medical Center

Investigators

  • Principal Investigator: KS Bae, Ph.D, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01369472
Other Study ID Numbers:
  • 125HPS11E
First Posted:
Jun 9, 2011
Last Update Posted:
Feb 15, 2012
Last Verified:
Feb 1, 2012
Additional relevant MeSH terms:
Angina, Stable
Carvedilol

Study Results

No Results Posted as of Feb 15, 2012