A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer

Healthy Volunteer Clinical Trial

— YH16410 DDI  

Official title:

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992601
• Other study ID #: YH16410-101
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2013
• Last updated: November 22, 2013
• Start date: November 2012
• Est. completion date: January 2013

Study information

• Verified date: November 2013
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also investigate drug interaction between separate and combination administration.

Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day administration, 16 days washout after 6th day of administration.

The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over design during 2 each period.

The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a cross-over design during 2 each period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Healthy male and female aged 20 to 50 with a body mass index(BMI) between 19 and 27 kg/m2

2. Acceptable medical history, physical examination, laboratory tests and EKG, during screening

3. Provision of signed written informed consent •20~50 yrs old, healthy Korean Subjects

Exclusion Criteria:

1.History of and clinically significant disease 2.Sitting blood pressure meeting the following criteria at screening: 150 = systolic blood pressure =90 (mmHg) and 95 = diastolic blood pressure = 50 (mmHg) amd 100 = Heart rate = 40 3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.

4. Administration of other investigational products within 90 days prior to the first dosing.

5. Administration of herbal medicine within 30 days or administration of ethical drugs within 14 days or administration of 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.Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of screening

7. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)
For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period. For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC	AUC t,ss of Rosuvastatin and Telmisartan	72hr	No
Primary	Cmax	Cmax,ss of Rosuvastatin and Telmisartan	72hr	No
Secondary	AUC	AUC last,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan	72hr	No
Secondary	AUC	AUC inf,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan	72hr	No
Secondary	Tmax	Tmax,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan	72hr	No
Secondary	t1/2	t1/2 of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan	72hr	No
Secondary	Cmin	Cmin,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan	72hr	No
Secondary	AUC	AUCt,ss of N-desmetyl Rosuvastatin	72hr	No
Secondary	Cmax	Cmax,ss of N-desmetyl Rosuvastatin	72hr	No