A Phase 1 Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Rosuvastatin and Telmisartan in Healthy Volunteers

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan in healthy volunteer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000584

Enrollment

Registered

2012-11-19

Start date

2012-11-26

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Group Subject number (n) Period 1 Period 2 1 12 A B 2 12 B A A: Administraion of Crestor Tab 20mg/day for 6days

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Part 1: AUCt,ss, Cmax,ss of rosuvastatin ;Part 2: AUCt,ss,Cmax,ss of telmisartan	—

Secondary

Measure	Time frame
Part 1: AUClast,ss, AUCinf,ss, Tmax,ss, t1/2, Cmin,ss of rosuvastatin and AUC?,ss, Cmax,ss, AUClast,ss, AUCinf,ss, Tmax,ss, t1/2, Cmin,ss of N-desmetyl rosuvastatin;Part 2: AUClast,ss, AUCinf,ss, Tmax,ss, t1/2, Cmin,ss of telmisartan	—

Countries

Korea, Republic of

Contacts

Public ContactMijeong Son

Yonsei University Health System, Severance Hospital

Outcome results