Chronopharmacology of Valsartan in Normotensive Subjects

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02631031
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The choice of drug administration time may affect the pharmacokinetics and/or drug response, and knowledge of any such circadian rhythm-dependent effects may help to reduce side effects or to enhance efficacy. This study designed to investigate the potential influence of the time of drug administration on the pharmacokinetics and pharmacodynamics of the valsartan in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy Normotensive Volunteers	Drug: Valsartan	Phase 1

Detailed Description

International guidelines recommend the use of long acting, once-daily medications that provide 24h efficacy; they improve adherence to therapy and minimize BP variability with smoother and more consistent BP control.

Valsartan has been approved to be used once-daily, without any specification of treatment-time in package insert. Several trials have investigated the differential effects of morning versus evening administration of valsartan in hypertensive patients, however, the results of these studies were contradicting. Furthermore, the specific administration time dependent dose response curve have not been previously investigated. So, this study designed to investigate the potential influence of the time of drug administration on the pharmacokinetics and pharmacodynamics of the valsartan in healthy subjects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparative Pharmacokinetic and Pharmacodynamic Study of Morning Versus Evening Administration of Valsartan in Healthy Adults
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: morning administration administration of single oral dose valsartan (160 mg) in the morning	Drug: Valsartan; single oral dose of 160 mg valsartan under fasting conditions; Other Names: Diovan
Other: evening administration administration of single oral dose valsartan (160 mg) in the evening	Drug: Valsartan; single oral dose of 160 mg valsartan under fasting conditions; Other Names: Diovan

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic parameters [blood samples will be collected for 48 hour after drug administration]

   Maximum plasma concentration (Cmax),

2. Pharmacokinetic parameters [blood samples will be collected for 48 hour after drug administration]

   Area under the curve (AUC).

3. Pharmacokinetic parameters [blood samples will be collected for 48 hour after drug administration]

   elimination half life (T1/2)

4. pharmacodynamic parameter [Blood samples will be measured at prespecified time points for 48 hour after drug administration]

   systolic blood pressure (mm Hg) ,diastolic blood pressure (mm Hg)

5. pharmacodynamic parameter [Blood samples will be measured at prespecified time points for 48 hour after drug administration]

   Heart rate (beat/min)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. At least 18 years old and not more than 45 healthy male volunteers

2. Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame

3. Who had passed all the screening parameters including physical examination, laboratory tests.

4. Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.

5. diurnal active subjects with eight hour night sleep.

6. free of any drug exposure known to interfere with the pharmacokinetics/pharmacodynamics or assay of valsartan for at least 10 days prior to the study

Exclusion Criteria:

1. Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.

2. Susceptibility to allergic reactions to valsartan.

3. Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.

4. Gastrointestinal diseases.

5. Renal diseases.

6. Cardiovascular diseases.

7. Pancreatic disease including diabetes.

8. Hepatic diseases.

9. Hematological disease or pulmonary disease

10. Abnormal laboratory values.

11. Subjects who have donated blood or who have been involved in multiple dosing study requiring a large volume of blood (more than 500 ml) to be drawn within 6 weeks preceding the start of the study.

12. Nocturnal active subjects

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams university	Cairo		Egypt	11566

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Noha Osama Mansour, Ph.D candidate Clinical pharmacy department, Faculty of pharmacy, Ain shams University, Ain Shams University
• ClinicalTrials.gov Identifier: NCT02631031
• Other Study ID Numbers: Ph.D (No.26)
• First Posted: Dec 15, 2015
• Last Update Posted: Aug 16, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Noha Osama Mansour, Ph.D candidate Clinical pharmacy department, Faculty of pharmacy, Ain shams University, Ain Shams University: Chronokinetics; chronodynamics; chronopharmacology; valsartan
• Additional relevant MeSH terms: Valsartan

Study Results

No Results Posted as of Aug 16, 2017