The pharmacokinetics and pharmcodynamics of felodipine and hydrochlorothiazide

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OPC-15006271
• Date of registration: 2015-04-17
• Prospective Registration: Yes
• Primary sponsor: Institute of Clinical Pharmacology, Central South University
• Public title: The pharmacokinetics and pharmcodynamics of felodipine and hydrochlorothiazide
• Scientific title: The pharmacokinetics and pharmcodynamics of felodipine and hydrochlorothiazide
• Date of first enrolment: 2015-04-23
• Target sample size: Case series:100;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=10806
• Study type: Observational study
• Study design: Case series
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Wei Zhang

• Name: Jianquan Luo
• Affiliation: Institute of Clinical Pharmacology, Central South University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Healthy men,aged between 19~40y,and the age years difference among the subjects is no more than 10y in one trial;
2. Weight over than 50kg, and in the scope of +/-10% ideal weight;
3. Without gastrointestinal tracts diseases, liver or severely kidney injury;
4. Without supersensitive history on drugs, and without postural hypotension;
5. Take no medicine drugs in last two weeks before trials;
6. All subjects sign the written informed consent.
Exclusion criteria: 1. Systolic blood pressure <100mm Hg, heart rate<50/min or>100/min;
2. With the supersensitive history on drugs, and supersensitive with telmisartan;
3. Participated other clinical trails in last three months, or taken any other drugs in last two weeks;
4. With gastrointestinal tracts diseases, liver or severely kidney injury.

Age minimum: 18
Age maximum: 40
Gender: Male

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Case series:felodipine 5mg; hydrochlorothiazide 25mg ;

Primary Outcome(s)

Blood drug concentration;

Source(s) of Monetary Support

Self-financing