Clinical trial NCT01369472: Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Stable Angina
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Asan Medical Center
First posted: 2011-06-09
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Dose-proportionality
timeFrame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
measure: Dose-proportionality
timeFrame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
measure: Dose-proportionality
timeFrame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
measure: Dose-proportionality
timeFrame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
measure: Dose-proportionality
timeFrame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Secondary outcomes:
measure: Safety
timeFrame: 0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d)
Other outcomes:
Locations:
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medcial Center
state: Seoul
Study officials:
affiliation: Asan Medical Center
name: KS Bae, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: