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

NCT01341392 | Completed Phase 1

• 1 other identifier: 19HPS11H
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Drug-Drug interaction between the CKD-501 and Amlodipine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (3)

CKD-501 0.5mg

EXPERIMENTAL

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.

Drug: CKD-501

CKD-501 Amlodipine

EXPERIMENTAL

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.

Drug: CKD-501 amlodipine

Amlodipine 10mg

EXPERIMENTAL

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.

Drug: amlodiopine

Interventions

CKD-501 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.

Also known as: Lobeglitazone

CKD-501 0.5mg

amlodiopine 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

CKD-501 amlodipine 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

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead
• Severance Hospital: collaborator

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 26163202 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Minsoo Park

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 22, 2011
• First Posted: April 25, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 15, 2011

Record last verified: 2011-08

Locations

KR (1)