Trial | NCT03609606  Report issue

Title

A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects
An Open-label, Randomized, Multiple-dose Crossover Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    69
A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
Study Started
Aug 09
2018
Primary Completion
Sep 14
2018
Study Completion
Sep 27
2018
Last Update
Oct 05
2018

Drug D013, D326 and D337 [dexamethasone, ckd-386]

Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days

  • Other names: CKD-386 Test

Drug D013

Daily oral administration of 1 tablet under fasting conditions for 7 days

  • Other names: CKD-386 Reference1

Drug D326 and D337 [dexamethasone, ckd-386]

Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days

  • Other names: CKD-386 Reference2

Part A, Sequence1 Experimental

Period 1: Treatment of D013, D326 and D337 on Day1~Day7 Period 2: Treatment of D013 on Day22~Day28

Part A, Sequence 2 Experimental

Period 1: Treatment of D013 on Day1~Day7 Period 2: Treatment of D013, D326 and D337 on Day22~Day28

Part B, Sequence 1 Experimental

Period 1: Treatment of D013, D326 and D337 on Day1~Day7 Period 2: Treatment of D326 and D337 on Day22~Day28

Part B, Sequence 2 Experimental

Period 1: Treatment of D326 and D337 on Day1~Day7 Period 2: Treatment of D013, D326 and D337 on Day22~Day28

Criteria 

Inclusion Criteria:

Healthy volunteers aged between ≥ 20 and ≤ 45 years old
Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm
Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study

Exclusion Criteria:

History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
Any medical history that may affect drug absorption, distribution, metabolism and excretion
Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
Any clinically significant active chronic disease
No Results Posted