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

Information source: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: CKD-501 (Drug); amlodiopine (Drug); CKD-501 amlodipine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Chong Kun Dang Pharmaceutical

Official(s) and/or principal investigator(s):
Minsoo Park, Principal Investigator, Affiliation: Severance Hospital

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.

Clinical Details

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

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

Primary outcome:

CKD-501 AUC

Amlodipine AUC

Secondary outcome:

CKD-5011 Tmax

Amlodipine Tmax

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.

Eligibility

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

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

Locations and Contacts

Severance Hospital, Seoul 120-752, Korea, Republic of
Additional Information

Starting date: April 2011
Last updated: August 11, 2011

Page last updated: August 23, 2015

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