Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Chronic Stable Angina

Treatments: Drug: Dilatrend SR capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01369472

125HPS11E

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 20 to 54 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Dilatrend SR capsule 8mg

Experimental group

Treatment:

Drug: Dilatrend SR capsule

Dilatrend SR capsule 16mg

Experimental group

Treatment:

Drug: Dilatrend SR capsule

Dilatrend SR capsule 32mg

Experimental group

Treatment:

Drug: Dilatrend SR capsule

Dilatrend SR capsule 64mg

Experimental group

Treatment:

Drug: Dilatrend SR capsule

Dilatrend SR capsule 128mg

Experimental group

Treatment:

Drug: Dilatrend SR capsule