Healthy Normotensive Participants
Conditions
Keywords
Healthy Normotensive Participants, Fixed dose combination, Pharmacokinetics, Losartan, Hydrochlorothiazide
Brief summary
This study was conducted to investigate any potential reaction between losartan and hydrochlorothiazide.
Interventions
Sponsors
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years old and not more than 45 healthy male volunteers * Who had passed all the screening parameters
Exclusion criteria
* A clinically significant abnormal physical exam, medical history, or laboratory studies * If they showed a sitting SBP of \>140 or \<100 mmHg, DBP \> 90 or \<60mm Hg, or a pulse rate of \> 95 or \< 50 beats/min at screening * The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days * A history of blood dyscrasias * A history of alcohol or drug abuse within the past year * Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study * Unable to tolerate vein puncture and multiple blood samplings * Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart rate | Participants will be followed for the duration of study, an expected average of 5 weeks. |
| Blood pressure | Participants will be monitored for the duration of study, an expected average of 5 weeks. |
| Pharmacokinetic parameter such as Cmax of losartan and hydrochlorothiazide | At the end of the study, after collection of all blood samples, an expected average of 4 weeks |
| Pharmacokinetic parameter such as AUC of losartan and hydrochlorothiazide | At the end of the study, after collection of all blood samples, an expected average of 4 weeks |
Outcome results
None listed