Study to Evaluate the Safety and Pharmacokinetics of CKD-... | NCT05089279

NCT05089279

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Sequence 1	Experimental	Period 1: D113/ Period 2: CKD-349	Drug: D113 Drug: CKD-349
Sequence2	Experimental	Period 1: CKD-349/ Period 2: D113	Drug: D113 Drug: CKD-349

Name	Type	Description	Arm Group Labels	Other Names
D113	Drug	QD, PO	Sequence 1 Sequence2
CKD-349

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCt of CKD-349	AUCt: Area under the concentration-time curve from time zero to time	0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Cmax of CKD-349	Cmax: Maximum plasma concentration of the drug	0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

Secondary Outcomes

Measure	Description	Time Frame
AUCinf of CKD-349	Area under the concentration-time curve from zero up to ∞	0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Tmax of CKD-349

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult volunteers aged ≥ 19 years
Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
Those who agree to contraception until 7 days after clinical trial.
Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

Those who have clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and urogenital system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products or take drugs that may interfere with this clinical trials within 10 day before the first administration
Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
Those who donated whole blood within 8 weeks or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks.
Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day
Those who overreacts to the ingredient of this drug and is administering an angiotensin conversion enzyme (ACE) inhibitor or has not passed 36 hours since discontinuation of administration and has a history of vascular edema when administering an angiotensin conversion enzyme (ACE) inhibitor or an angiotensin receptor antagonist (ARB).
Those who are deemed insufficient to participate in this clinical study by investigators.
Woman who are pregnant or breastfeeding.