Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)
Information source: Yuhan Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Telmisartan (Drug); Amlodipine (Drug); Chlorthalidone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Yuhan Corporation Official(s) and/or principal investigator(s): Dong Seok Yim, Principal Investigator, Affiliation: The Catholic University of Korea
Summary
To evaluate Drug-drug interaction
Clinical Details
Official title: An Open-label, Multiple-dose, Two-arm Clinical Study to Evaluate the Drug-drug Interaction and Safety of Telmisartan, Amlodipine and/or Chlorthalidone in Healthy Adult Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone
Secondary outcome: Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone
Detailed description:
The purpose of this study is to evaluate the Drug-Drug(telmisartan, amlodipine and/ or
chlorthalidone) interaction and safety in healthy adult volunteers.
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal
body weight of 80-120% (ideal body weight)
2. Who has not suffered from clinically significant disease
3. Provision of signed written informed consent
Exclusion Criteria:
1. History of and clinically significant disease psychiatric, or malignancy.
2. A history of drug abuse or the presence of positive reactions to drugs that have
abuse potential in urine screenings for drugs.
3. Administration of other investigational products within 3 months prior to the first
dosing.
4. 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).
5. Volunteers considered not eligible for the clinical trial by the investigator (study
doctor) due to reasons including laboratory test results, ECGs, or vital signs.
Locations and Contacts
The Catholic University of Korea Seoul St.Mary's Hospital, Seoul, Korea, Republic of
Additional Information
Starting date: May 2014
Last updated: November 18, 2014
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