A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical

Criteria

Inclusion Criteria:

1. Healthy volunteers aged between ≥20 and ≤45 years old

2. Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2

3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings

4. Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests

5. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

1. History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug

2. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption

3. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests