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

NCT ID: NCT01341392

Last Updated: 2011-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-08-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CKD-501 0.5mg

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.

Group Type: EXPERIMENTAL

CKD-501

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

CKD-501 amlodipine

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

amlodiopine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Lobeglitazone

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Severance Hospital

OTHER

Sponsor Role: collaborator

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Chong Kun Dang Pharmaceutical

Principal Investigators

Minsoo Park

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

References

Kim CO, Sil Oh E, Kim C, Park MS. Pharmacokinetic Interaction Between Amlodipine and Lobeglitazone, a Novel Peroxisome Proliferator-activated Receptor-gamma Agonist, in Healthy Subjects. Clin Ther. 2015 Sep;37(9):1999-2006.e1. doi: 10.1016/j.clinthera.2015.06.009. Epub 2015 Jul 7.

Reference Type: DERIVED

PMID: 26163202 (View on PubMed)

Other Identifiers

19HPS11H

Identifier Type: -

Identifier Source: org_study_id