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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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT01340248
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
1
Duration (Months)
23.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dilatrend 64mg capsule
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dilatrend 64mg capsule

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. evaluation of safety [from screenig to post-study visit]

    adverse event monitoring physical examination, vital sign, ECOG, laboratory test

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kyungpook national university Daegu Seoul Korea, Republic of 700-721

Sponsors and Collaborators

  • Chong Kun Dang Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01340248
Other Study ID Numbers:
  • 125HPS11F
First Posted:
Apr 22, 2011
Last Update Posted:
Dec 22, 2011
Last Verified:
Apr 1, 2011
Keywords provided by , ,
food effect
pharmacokinetics
healthy male volunteers
Additional relevant MeSH terms:
Angina, Stable
Carvedilol

Study Results

No Results Posted as of Dec 22, 2011