Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide

NCT01858623 | Completed DMC

• 1 other identifier: PPT5
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted to investigate any potential reaction between losartan and hydrochlorothiazide.

Conditions

Healthy Normotensive Participants

Keywords

Healthy Normotensive Participants; Fixed dose combination; Pharmacokinetics; Losartan; Hydrochlorothiazide

Outcome Measures

Primary Outcomes (4)

• Heart rate

  Participants will be followed for the duration of study, an expected average of 5 weeks.

• Blood pressure

  Participants will be monitored for the duration of study, an expected average of 5 weeks.

• Pharmacokinetic parameter such as Cmax of losartan and hydrochlorothiazide

  At the end of the study, after collection of all blood samples, an expected average of 4 weeks

• Pharmacokinetic parameter such as AUC of losartan and hydrochlorothiazide

  At the end of the study, after collection of all blood samples, an expected average of 4 weeks

Study Arms (3)

Losartan / Hydrochlorothiazide100 mg/25mg

OTHER

Losartan / Hydrochlorothiazide100 mg/25mg fixed dose combination

Drug: Losartan/hydrochlorothiazide

Losartan 100 mg

OTHER

Losartan 100 mg alone

Drug: Losartan

hydrochlorothiazide 25 mg

OTHER

hydrochlorothiazide 25 mg alone

Drug: Hydrochlorothiazide

Interventions

Losartan/hydrochlorothiazide DRUG

Losartan / Hydrochlorothiazide100 mg/25mg

Losartan DRUG

Losartan 100 mg

Hydrochlorothiazide DRUG

hydrochlorothiazide 25 mg

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
• Who had passed all the screening parameters

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
• The use of any prescription drug within the previous month or use of any over-the-counter medication 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

Sponsors & Collaborators

• Damanhour University: lead

MeSH Terms

Interventions

hydrochlorothiazide, losartan drug combination; Losartan; Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; 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: May 12, 2013
• First Posted: May 21, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 27, 2013

Record last verified: 2013-05