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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: CKD-501, Ketoconazole

• Registration Number: NCT01330563
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-07
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-28
• Last Update Posted: 2011-06-29

Recruitment & Eligibility

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

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CKD-501	CKD-501, 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
ketoconazole	CKD-501, 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

Primary Outcome Measures

Name	Time	Method
CKD-501 AUC	0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr

Secondary Outcome Measures

Name	Time	Method
CKD-501 Cmax	0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr
CKD-501 Tmax	0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of