Drug-drug Interaction Study (CKD-501, Ketoconazole)

This study has been completed.

Sponsor:

Collaborator:

Severance Hospital

Information provided by:

Chong Kun Dang Pharmaceutical

ClinicalTrials.gov Identifier:

NCT01330563

First received: April 5, 2011

Last updated: June 28, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 5, 2011

Last Updated Date

June 28, 2011

Start Date ^ICMJE

March 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CKD-501 AUC [ Time Frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01330563 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

CKD-501 Cmax [ Time Frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr ] [ Designated as safety issue: No ]
CKD-501 Tmax [ Time Frame: 0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Drug-drug Interaction Study (CKD-501, Ketoconazole)

Official Title ^ICMJE

Drug-Drug Interaction Study to Investigate the Effect of Ketoconazole on the Pharmacokinetic Properties of CKD-501 in Healthy Male Volunteer: Open, Randomised, 2-way Crossover, Clinical Trial

Brief Summary

The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic characteristics of CKD-501 in healthy subject.

Detailed Description

From day 1 to day 5, Ketoconazole 200mg is administered twice daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg is co-administered Group 1 patients at period 1. After 28 day-break, period 2 will CKD-501 0.5mg administered on day 5. Period 2 will not Ketoconazole administered.

Group 2 is administered in reverse order.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: CKD-501, Ketoconazole

Subjects received single 0.5mg doses of CKD-501 alone in one period and, in the other period, Ketoconazole 200 mg twice daily for 5 day with the CKD-501 dose also co-administered with Ketoconazole on day 5.

Other Name: Lobeglitazone, Ketoconazole

Study Arm (s)

Experimental: CKD-501
Subjects received Ketoconazole 200 mg twice daily for 5 days in one period and in the other period, Subjects don't receive Ketoconazole.

In addition, The CKD-501 is administered on day 5

Intervention: Drug: CKD-501, Ketoconazole
Experimental: ketoconazole
Subjects received Ketoconazole 200 mg twice daily for 5 days in one period and in the other period, Subjects don't receive Ketoconazole.

In addition, The CKD-501 is administered on day 5

Intervention: Drug: CKD-501, Ketoconazole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Between 20 aged and 45 years old in healthy males
18.5 ≤ IBW < 25
Agreement with written informed consent

Exclusion Criteria:

Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
Medication with drug-mediated induction/inhibition metabolic enzyme such as Midazolam within 1 month or with may affect the clinical trial
Subject has taken abnormal meals which affects the ADME of drug
Subject has a history(such as gastric or duodenal ulcer, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
Substance abuse, or a history of drug abuse showed a positive for the party
Continued to be taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
Previously participated in other trial within 60 days
Previously donate whole blood within 60 days or component blood within 30 days
Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
SBP >140 mmHg, SBP < 90 mmHg or DBP > 90 mmHg, DBP < 50 mmHg or Pulse > 100 per/min, Pulse < 50 per/min
12-lead ECG, QTc > 450 msec
An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Gender

Male

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01330563

Other Study ID Numbers ^ICMJE

19HPS11G

Has Data Monitoring Committee

Responsible Party

Chong Kun Dang Pharmaceutical, Chin Kim

Study Sponsor ^ICMJE

Chong Kun Dang Pharmaceutical

Collaborators ^ICMJE

Severance Hospital

Investigators ^ICMJE

Principal Investigator:

Minsoo Park

Severance Hospital

Information Provided By

Chong Kun Dang Pharmaceutical

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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