Trial | NCT01767259  Report issue

Title

Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide
Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide: An Open-Label, Randomized, Four-Period Crossover Study in Healthy Egyptian Male Volunteers

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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.
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.
Study Started
Oct 31
2012
Primary Completion
Dec 31
2012
Study Completion
Dec 31
2012
Last Update
Jan 15
2013
Estimate

Drug Valsartan/Hydrochlorothiazide

Co-administration or fixed dose combination

  • Other names: Fixed dose combination, Pharmacokinetic interaction

Drug Valsartan

Valsartan alone

Drug Hydrochlorothiazide

Hydrochlorothiazide alone

Valsartan 160 mg alone Other

Valsartan alone

Hydrochlorothiazide 12.5 mg alone Other

Hydrochlorothiazide alone

Valsartan160 mg + Hydrochlorothiazide12.5 mg Other

Concomitant administration of valsartan 160 mg + Hydrochlorothiazide 12.5 mg

Valsartan / Hydrochlorothiazide 160 mg/12.5mg Other

Fixed dose combination of valsartan 160 mg + Hydrochlorothiazide 12.5 mg

Criteria 

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.
No Results Posted