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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: CKD-501; Drug: CKD-501 amlodipine; Drug: amlodiopine

• Registration Number: NCT01341392
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.

Detailed Description

Volunteers doses three times over the period of CKD-501 0.5mg or Amlodipine 10mg alone/co-administrate, repeated doses are 10 days.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-22
• Study First Submitted QC: 2011-04-22
• Study First Posted: 2011-04-25
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-11
• Last Update Posted: 2011-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Between 20 aged and 45 years old in healthy males
• Body weight ≥ 55kg and 18.5 ≤ IBW < 25
• Agreement with written informed consent

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Exclusion Criteria

• Subject has a history affects the ADME of drug
• Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
• Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test)
• AST,ALT > UNL * 1.25 or Total bilirubin > UNL * 1.5
• Estimated GFR(MDRD) < 80
• SBP >150 mmHg, SBP < 100 mmHg or DBP > 100 mmHg, DBP < 60 mmHg or Pulse > 100 per/min, Pulse < 50 per/min
• 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
• Medication with drug-mediated induction/inhibition metabolic enzyme within 30 days or with may affect the clinical trial
• Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
• Subject takes grapefruit within 1 month
• Previously participated in other trial within 60 days
• Previously donate whole blood within 60 days or component blood within 30 days
• 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKD-501 0.5mg	CKD-501	Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
CKD-501 Amlodipine	CKD-501 amlodipine	Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
Amlodipine 10mg	amlodiopine	Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.

Primary Outcome Measures

Name	Time	Method
CKD-501 AUC	Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr
Amlodipine AUC	Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr

Secondary Outcome Measures

Name	Time	Method
CKD-5011 Tmax	Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr
Amlodipine Tmax	Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of