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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Amlodipine After Oral Administration in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341392
• Other study ID #: 19HPS11H
• Status: Completed
• Phase: Phase 1
• First received: April 22, 2011
• Last updated: August 11, 2011
• Start date: April 2011
• Est. completion date: August 2011

Study information

• Verified date: August 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 pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2011
• Est. primary completion date: August 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

• 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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 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.
• 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.
• 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.

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		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	No
Primary	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	No
Secondary	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	No
Secondary	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	No