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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330563
• Other study ID #: 19HPS11G
• Status: Completed
• Phase: Phase 1
• First received: April 5, 2011
• Last updated: June 28, 2011
• Start date: March 2011
• Est. completion date: June 2011

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CKD-501 AUC		0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr	No
Secondary	CKD-501 Cmax		0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr	No
Secondary	CKD-501 Tmax		0(Day 5), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48hr	No