Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule

Phase 1

Completed

• Conditions: Chronic Stable Angina
• Interventions: Drug: Dilatrend SR capsule

• Registration Number: NCT01369472
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-21
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dilatrend SR capsule 8mg	Dilatrend SR capsule	-
Dilatrend SR capsule 16mg	Dilatrend SR capsule	-
Dilatrend SR capsule 32mg	Dilatrend SR capsule	-
Dilatrend SR capsule 64mg	Dilatrend SR capsule	-
Dilatrend SR capsule 128mg	Dilatrend SR capsule	-

Primary Outcome Measures

Name	Time	Method
Dose-proportionality	0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h	t½β

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medcial Center; 🇰🇷 Songpa-gu, Seoul, Korea, Republic of