Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule

Chronic Stable Angina Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369472
• Other study ID #: 125HPS11E
• Status: Completed
• Phase: Phase 1
• First received: April 21, 2011
• Last updated: February 13, 2012
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: February 2012
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 54 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Chronic Stable Angina

Intervention

Drug:
• Dilatrend SR capsule
single oral administration in period 1 or 2, 3 for each sequential group.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medcial Center	Songpa-gu	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-proportionality	AUClast	0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h	Yes
Primary	Dose-proportionality	AUC0-8	0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h	Yes
Primary	Dose-proportionality	Cmax	0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h	Yes
Primary	Dose-proportionality	Tmax	0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h	Yes
Primary	Dose-proportionality	t½ß	0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h	Yes
Secondary	Safety	Adverse Event/Serious Adverse Event monitoring Physical Examination, Vital Sign, 12-lead ECG, Lab Tests	0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d)	Yes