A Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects

Hypertension Clinical Trial

Official title:

A Randomized, Open Label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and Safety Among D326, D337 and CKD-828 in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03726866
• Other study ID #: 186DDI18020
• Status: Recruiting
• Phase: Phase 1
• Start date: August 31, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: October 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: Jihwan Oh
• Phone: 82-2-6373-0953
• Email: jihwan[@]ckdpharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Healthy volunteers aged between = 19 and = 40 years old

2. Calculated body mass index(BMI) of = 19 and = 28kg/m²

3. Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial

4. Subject who agree not to provide sperm

5. Subject who voluntarily agree to participate in this study

Exclusion Criteria:

1. Any medical history that may affect drug absorption, distribution, metabolism and excretion

2. Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.

3. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder

4. Subject who have received other clinical trial drugs within 90 days prior to the screening visit

5. Any clinically significant active chronic disease

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• Sequence 1
D326, D337 or CKD-828 for 9 days
• Sequence 2
D326, D337 or CKD-828 for 9 days
• Sequence 3
D326, D337 or CKD-828 for 9 days
• Sequence 4
D326, D337 or CKD-828 for 9 days
• Sequence 5
D326, D337 or CKD-828 for 9 days
• Sequence 6
D326, D337 or CKD-828 for 9 days

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, University of Ulsan	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax(Maximum plasma concentration of the drug at steady state)	PK parameters of D326, D337 and CKD-828	at Day 9
Primary	AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)	PK parameters of D326, D337 and CKD-828	at Day 9
Secondary	Tmax(Time to maximum plasma concentration at steady state)	PK parameters of D326, D337 and CKD-828	at Day 9
Secondary	t1/2(Terminal elimination half-life)	PK parameters of D326, D337 and CKD-828	at Day 9