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

• Sponsor: Yuhan Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02152969
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 10.9

Study Details

Study Description

Brief Summary

To evaluate Drug-drug interaction

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Telmisartan; Drug: Amlodipine; Drug: Chlorthalidone	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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 Start Date: May 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone [Totally 28points for 24 hours]

Secondary Outcome Measures

1. Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone [Totally 28points for 24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Catholic University of Korea Seoul St.Mary's Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yuhan Corporation

Investigators

• Principal Investigator: Dong Seok Yim, The Catholic University of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuhan Corporation
• ClinicalTrials.gov Identifier: NCT02152969
• Other Study ID Numbers: YH22162-101
• First Posted: Jun 2, 2014
• Last Update Posted: Nov 19, 2014
• Last Verified: Nov 1, 2014

• Additional relevant MeSH terms: Hypertension; Amlodipine; Telmisartan; Chlorthalidone

Study Results

No Results Posted as of Nov 19, 2014