Healthy Normotensive Participants
Conditions
Keywords
Fixed dose combination, Pharmacokinetics, Valsartan, Hydrochlorothiazide
Brief summary
This study was conducted to compare the rate and extent of absorption of valsartan and hydrochlorothiazide following oral administration as a fixed dose combination tablet and concomitant administration of the individual drugs under fasting conditions in healthy Egyptian subjects. The study was extended to investigate any potential reaction between VAL and HCT.
Detailed description
This study comprised 2 separate parts, I and II; each was a single-dose, open-label, 4-crossover periods separated by a 2 weeks washout, and 4-Treatments. Part I consisted of Treatments A (VAL 160 mg alone), B (HCT 12.5 mg alone), C (VAL 160 mg + HCT 12.5 mg) and D (VAL / HCT 160 mg/12.5mg) and Part II consisted of Treatments E (VAL 320 mg alone), F (HCT 25 mg alone), G (VAL 320 mg + HCT 25 mg) and H (VAL / HCT 320 mg/25 mg). Blood samples were collected up to 48 hours postdose and plasma was analyzed for VAL and HCT concentrations using HPLC. The pharmacokinetic properties of each drug after co-administration of VAL and HCT were compared with those of each drug administered alone.
Interventions
Co-administration or fixed dose combination
DRUGValsartan
Valsartan alone
DRUGHydrochlorothiazide
Hydrochlorothiazide alone
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 * Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame * Who had passed all the screening parameters * Free of any drug exposure known to interfere with the pharmacokinetics or assay of fexofenadine for at least 10 days prior to the study * Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.
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 * A history of serious intolerance, allergy, or sensitivity to fexofenadine * The use of any prescription drug within the previous month or use of any over-the-counter medication (with the exception of acetaminophen) 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 * Cannot follow instructions, in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability | Participants will be followed for the duration of study, an expected average of 6 weeks. | Tolerability was assessed based on changes in vital signs (temperature, blood pressure, pulse, and heart rate), measured before dosing in each period and approximately every 4 hours thereafter, and laboratory tests (hematology, biochemistry, liver function, and urinalysis), and performed at baseline and at the end of the study. In addition, a physician questioned volunteers about any adverse events occurring during the study, addressed them as necessary, and recorded them on the appropriate form. This physician was not blinded to treatment, but had no involvement in the study. |
Countries
Egypt
Outcome results
None listed