A Phase 1 Clinical Trial to Investigate Pharmacokinetics and Bioequivalence of the co-administration of telmisartan and rosuvastatin and YH16410

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0001231
• Lead Sponsor: Yuhan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1)Healthy male and female aged 20 to 50.
2)Who has no congenital or chronic medical history and whose results of physical examination are not clinically significant.
3)Who voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written informed consent form.

Exclusion Criteria

1)Who has disease or history of clinically significant disease.
2)Whose Sitting blood pressure meeting clinically abnormal.
3)Whose history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
4)Who has administered other investigational products within 90 days prior to the first dosing.
5)Who has administered herbal medicine within 28 days or ethical drugs within 14 days or over-the-counter (OTC) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
6)Whose Aspartate aminotransferase(AST) or/and Alanine aminotransferase(ALT) level > 3 times of normal upper limit at the time of screening.
7)Whose Creatine kinase(CK) level > 5 times of normal upper limit at the time of screening.
8)Who suffering from moderate or severe renal failure with damaged renal (Glomerular filtration rate(GFR) <60 ml/min/1.73m^2).
9)Who considered not eligible for the clinical trial by the investigator (study do
ctor).

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUClast, Cmax of telmisartan and rosuvastatin

Secondary Outcome Measures

Name	Time	Method
AUCinf, Tmax, t1/2, %AUCextra of telmisartan, rosuvastatin and N-desmethyl rosuvastatin. AUClast, Cmax of N-desmethyl rosuvastatin