Clinical trial NCT02233218: The Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
Official title: A Phase 1, Open Label, Non-randomized, Two-cohort, Single-sequence, Crossover Study to Investigate the Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteer
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2014-09-08
Enrollment: 60
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate the pharmacokinetic Drug-drug interaction

Detailed description: The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan, amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.

Eligibility criteria: Inclusion Criteria:

1. Healthy male volunteers aged 19 to 50
2. Participant who has a body weight that is \>=55kg(male) and body mass index (BMI) level that is 18\~30
3. Provision of signed written informed consent

Exclusion Criteria:

1. History of clinically significant disease
2. History of clinically significant hypersensitivity or hypersensitivity reactions to drugs and other medications (aspirin, antibiotics, etc.), including components such as Telmisartan, Rosuvastatin and Amlodipine
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 2 months prior to the first dosing.
5. Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week 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. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to the reasons including laboratory test results, ECGs, or vital signs.

Primary outcomes:
measure: Area under the plasma/serum/blood drug concentration-time curve in steady-state of Telmisartan and Amlodipine
timeFrame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Maximum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine
timeFrame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Area under the plasma/serum/blood drug concentration-time curve in steady-state of Rosuvastatin
timeFrame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Maximum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin
timeFrame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Secondary outcomes:
measure: Time of peak concentration in steady state of Telmisartan and Amlodipine
timeFrame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Minimum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine
timeFrame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Area under the plasma/serum/blood drug concentration-time curve in steady-state of N- desmethyl rosuvastatin
timeFrame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Maximum concentration of drug in plasma/serum/blood in steady-state of N- desmethyl rosuvastatin
timeFrame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Time of peak concentration in steady state of rosuvastatin and N- desmethyl rosuvastatin
timeFrame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Minimum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin and N- desmethyl rosuvastatin
timeFrame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Dong-A university hospital
Study officials:
affiliation: Dong-A university hospital of Korea
name: Minkgyu Park, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References: