Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule - Full Text View

Purpose

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

Condition	Intervention	Phase
Chronic Stable Angina	Drug: Dilatrend SR capsule	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Angina

Drug Information available for: Carvedilol

U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:

Dose-proportionality [ Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h ] [ Designated as safety issue: Yes ]
AUClast
Dose-proportionality [ Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h ] [ Designated as safety issue: Yes ]
AUC0-∞
Dose-proportionality [ Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h ] [ Designated as safety issue: Yes ]
Cmax
Dose-proportionality [ Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h ] [ Designated as safety issue: Yes ]
Tmax
Dose-proportionality [ Time Frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h ] [ Designated as safety issue: Yes ]
t½β

Secondary Outcome Measures:

Safety [ Time Frame: 0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d) ] [ Designated as safety issue: Yes ]
Adverse Event/Serious Adverse Event monitoring Physical Examination, Vital Sign, 12-lead ECG, Lab Tests

Enrollment:	30
Study Start Date:	June 2011
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	20 Years to 54 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369472

Locations

Korea, Republic of
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

More Information

No publications provided

Responsible Party:	Jin Kim / Director, Clincal Research Department
ClinicalTrials.gov Identifier:	NCT01369472 History of Changes
Other Study ID Numbers:	125HPS11E
Study First Received:	April 21, 2011
Last Updated:	February 13, 2012
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on June 17, 2013