Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses)

NCT01767298 | Completed DMC

• 1 other identifier: PPT1 PART II
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted to compare the rate and extent of absorption of valsartan and hydrochlorothiazide. To maximize the possibility of finding drug-drug interactions, the dose of valsartan and hydrochlorothiazide was doubled (320 mg of VAL and 25 mg of HCT).

Conditions

Healthy Normotensive Participants

Keywords

Fixed dose combination; Pharmacokinetics; Valsartan; Hydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

• Tolerability

  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.

  Participants will be followed for the duration of study, an expected average of 6 weeks.

Study Arms (4)

Valsartan 320 mg alone

OTHER

Valsartan alone

Drug: Valsartan

Hydrochlorothiazide 25 mg alone

OTHER

Hydrochlorothiazide alone

Drug: Hydrochlorothiazide

Valsartan 320 mg + Hydrochlorothiazide 25 mg

OTHER

Concomitant administration of valsartan 320 mg + Hydrochlorothiazide 25 mg

Drug: Valsartan/Hydrochlorothiazide

Valsartan / Hydrochlorothiazide 320 mg/25mg

OTHER

Fixed dose combination of valsartan 320 mg + Hydrochlorothiazide 25 mg

Drug: Valsartan/Hydrochlorothiazide

Interventions

Valsartan/Hydrochlorothiazide DRUG

Co-administration or fixed dose combination

Valsartan / Hydrochlorothiazide 320 mg/25mg; Valsartan 320 mg + Hydrochlorothiazide 25 mg

Valsartan DRUG

Valsartan alone

Valsartan 320 mg alone

Hydrochlorothiazide DRUG

Hydrochlorothiazide alone

Hydrochlorothiazide 25 mg alone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

MeSH Terms

Interventions

Valsartan; Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pharmaceutics, Faculty of Pharmacy

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 14, 2013
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 14, 2013

Record last verified: 2013-01