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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01369472

Enrollment

Registered

2011-06-09

Start date

2011-06-30

Completion date

2011-10-31

Last updated

2012-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stable Angina

Brief summary

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

Interventions

DRUGDilatrend SR capsule

single oral administration in period 1 or 2, 3 for each sequential group.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 54 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Dose-proportionality	0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h	AUClast

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026