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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: CKD-501 amlodipine; Drug: CKD-501; Drug: amlodiopine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01341392

19HPS11H

Details and patient eligibility

About

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

Full description

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

Enrollment: 25 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

CKD-501 0.5mg

Experimental group

Description:

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.

Treatment:

Drug: CKD-501

CKD-501 Amlodipine

Experimental group

Description:

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.

Treatment:

Drug: CKD-501 amlodipine

Amlodipine 10mg

Experimental group

Description:

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.

Treatment:

Drug: amlodiopine