A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers

NCT01340248 | Completed Phase 1

• 1 other identifier: 125HPS11F
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy male volunteers.

Conditions

Chronic Stable Angina

Keywords

food effect; pharmacokinetics; healthy male volunteers

Outcome Measures

Primary Outcomes (1)

• evaluation of pharmacokinetics

  The effect of food on PK after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions

  pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48h

Secondary Outcomes (1)

• evaluation of safety

  from screenig to post-study visit

Study Arms (1)

Dilatrend 64mg capsule

EXPERIMENTAL

\* Randomized, open-label, single dose, two-period, two-way, crossover study 1. group : Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet 2. group : Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting

Drug: Dilatrend 64mg capsule

Interventions

Dilatrend 64mg capsule DRUG

1. Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet 2. Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting

Dilatrend 64mg capsule

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 20 aged and 50 aged in healthy adults
• Weight more than 55kg, IBW 20% within the range
• Agreement with written informed consent

You may not qualify if:

• Subject has hypersensitivity reaction or clinically significant history about investigational drug
• Clinically significant cardiovascular system, respiratory system, liver, renal, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease and so on
• Inadequate result of laboratory test
• AST(SGOT) or ALT(SGPT) \> 1.5 x upper limit of normal range
• Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 210 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette \> 10 cigarettes per day)
• Creatinine clearance \< 80ml/min
• Subject with known for history(such as gastrointestinal disease or operation) with affect the absorption of drug
• Subject takes an abnormal meal which affect the ADME of drug
• Previously participated in other trial within 90 days
• Previously make whole blood donation within 60 days or component blood donation within 30 days
• Subject with positive reaction for reason of laboratory test result
• An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Kyungpook national university

Daegu, Seoul, 700-721, South Korea

Location

MeSH Terms

Conditions

Angina, Stable

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 22, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 22, 2011

Record last verified: 2011-04

Locations

KR (1)