Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)

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

To evaluate Drug-drug interaction

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Telmisartan; Drug: Amlodipine; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Seoul St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Part B; Arm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan.	Drug: Telmisartan; Drug: Amlodipine; Drug: Chlorthalidone
Other: Part A; Arm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone.	Drug: Telmisartan; Drug: Amlodipine; Drug: Chlorthalidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone	Totally 28points for 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone	Totally 28points for 24 hours

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Dong Seok Yim, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 29, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Estimate): November 19, 2014
• Last Update Submitted That Met QC Criteria: November 18, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Amlodipine; Chlorthalidone; Telmisartan
• Other Study ID Numbers: YH22162-101