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

Phase 1

Completed

• Conditions: Chronic Stable Angina
• Interventions: Drug: Dilatrend 64mg capsule

• Registration Number: NCT01340248
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Study Start: 2011-07
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-12-20
• Last Update Posted: 2011-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dilatrend 64mg capsule	Dilatrend 64mg capsule	\* 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

Primary Outcome Measures

Name	Time	Method
evaluation of pharmacokinetics	pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48h	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

Secondary Outcome Measures

Name	Time	Method
evaluation of safety	from screenig to post-study visit	* adverse event monitoring; * physical examination, vital sign, ECOG, laboratory test

Trial Locations

Locations (1)

Kyungpook national university; 🇰🇷 Daegu, Seoul, Korea, Republic of