Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule
CompletedPhase 1NCT01369472
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.
Study details
- 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
- Conditions
- Interventions
- Drug: Dilatrend SR capsule
- Sponsor
- Chong Kun Dang Pharmaceutical
- Collaborators
- Asan Medical Center
- Start date
- 2011-06
- Primary completion
- 2011-10
- Sex
- Male
- Age range
- from 20 Years to 54 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- South Korea
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01369472