A Study to Investigate Drug Interaction Between D326, D337, and D013 in Healthy Male Subjects

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Hypertension; Dyslipidemias

Treatments: Drug: D326 and D337; Drug: D013, D326 and D337; Drug: D013

Study type: Interventional

Funder types: Industry

Identifiers

NCT03609606

183DDI18011

Details and patient eligibility

About

A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects

Full description

An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects

Enrollment: 69 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy volunteers aged between ≥ 20 and ≤ 45 years old
2. Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
3. 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
4. Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study

Exclusion criteria

1. History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
3. Any medical history that may affect drug absorption, distribution, metabolism and excretion
4. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
5. Any clinically significant active chronic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

69 participants in 4 patient groups

Part A, Sequence1

Experimental group

Description:

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

Treatment:

Drug: D013

Drug: D013, D326 and D337

Part A, Sequence 2

Experimental group

Description:

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

Treatment:

Drug: D013

Drug: D013, D326 and D337

Part B, Sequence 1

Experimental group

Description:

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

Treatment:

Drug: D013, D326 and D337

Drug: D326 and D337

Part B, Sequence 2

Experimental group

Description:

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

Treatment:

Drug: D013, D326 and D337

Drug: D326 and D337