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Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide

Information source: Damanhour University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Normotensive Participants

Intervention: Valsartan/Hydrochlorothiazide (Drug); Valsartan (Drug); Hydrochlorothiazide (Drug)

Phase: N/A

Status: Completed

Sponsored by: Damanhour University

Official(s) and/or principal investigator(s):
Sally Helmy, PhD, CPHQ, Principal Investigator, Affiliation: Pharmaceutics Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Tolerability

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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.

Locations and Contacts

Pharmaceutics Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt
Additional Information

Starting date: October 2012
Last updated: January 12, 2013

Page last updated: August 23, 2015

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