Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide

NCT ID: NCT01767259

Last Updated: 2013-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2012-12-31

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.

Conditions

Healthy Normotensive Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Valsartan 160 mg alone

Valsartan alone

Group Type: OTHER

Valsartan

Intervention Type: DRUG

Valsartan alone

Hydrochlorothiazide 12.5 mg alone

Hydrochlorothiazide alone

Group Type: OTHER

Hydrochlorothiazide

Intervention Type: DRUG

Hydrochlorothiazide alone

Valsartan160 mg + Hydrochlorothiazide12.5 mg

Concomitant administration of valsartan 160 mg + Hydrochlorothiazide 12.5 mg

Group Type: OTHER

Valsartan/Hydrochlorothiazide

Intervention Type: DRUG

Co-administration or fixed dose combination

Valsartan / Hydrochlorothiazide 160 mg/12.5mg

Fixed dose combination of valsartan 160 mg + Hydrochlorothiazide 12.5 mg

Group Type: OTHER

Valsartan/Hydrochlorothiazide

Intervention Type: DRUG

Co-administration or fixed dose combination

Interventions

Valsartan/Hydrochlorothiazide

Co-administration or fixed dose combination

Intervention Type: DRUG

Valsartan

Valsartan alone

Intervention Type: DRUG

Hydrochlorothiazide

Hydrochlorothiazide alone

Intervention Type: DRUG

Other Intervention Names

Fixed dose combination; Pharmacokinetic interaction

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Sally Helmy, PhD, CPHQ

Lecturer of Pharmaceutics, Faculty of Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sally Helmy, PhD, CPHQ

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Pharmaceutics Department, Faculty of Pharmacy, Damanhour University

Damanhur, , Egypt

Countries

Egypt

Other Identifiers

PPT1

Identifier Type: -

Identifier Source: org_study_id