Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Stable Angina
• Intervention / Treatment: Drug: Dilatrend SR capsule

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Songpa-gu, Seoul, Korea, Republic of, 138-736
      • Asan Medcial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Adverse Event/Serious Adverse Event monitoring Physical Examination, Vital Sign, 12-lead ECG, Lab Tests	0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d)

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Collaborators: Asan Medical Center
• Investigators: Principal Investigator: KS Bae, Ph.D, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (Estimate): June 9, 2011

Study Record Updates

• Last Update Posted (Estimate): February 15, 2012
• Last Update Submitted That Met QC Criteria: February 13, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Protective Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Antioxidants; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Carvedilol
• Other Study ID Numbers: 125HPS11E