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

Chronic Stable Angina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340248
• Other study ID #: 125HPS11F
• Status: Completed
• Phase: Phase 1
• First received: April 20, 2011
• Last updated: December 20, 2011
• Start date: July 2011
• Est. completion date: August 2011

Study information

• Verified date: April 2011
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Between 20 aged and 50 aged in healthy adults

• Weight more than 55kg, IBW 20% within the range

• Agreement with written informed consent

Exclusion Criteria:

• 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

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 64mg capsule
Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook national university	Daegu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	evaluation of safety	adverse event monitoring; physical examination, vital sign, ECOG, laboratory test	from screenig to post-study visit	Yes