Healthy Normotensive VolunteersPhase 1NCT02631031
Chronopharmacology of Valsartan in Normotensive Subjects
A Phase 1 study testing Valsartan in people with Healthy Normotensive Volunteers, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Normotensive Volunteers
- What is being tested?
- Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2015to Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 including physical examination, laboratory tests.
- Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.
- diurnal active subjects with eight hour night sleep.
- 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
Who cannot join
- Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
- Susceptibility to allergic reactions to valsartan.
- Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- Gastrointestinal diseases.
- Renal diseases.
- Cardiovascular diseases.
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- Pancreatic disease including diabetes.
- Hepatic diseases.
- Hematological disease or pulmonary disease
- Abnormal laboratory values.
- 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.
- Nocturnal active subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Pharmacokinetic and Pharmacodynamic Study of Morning Versus Evening Administration of Valsartan in Healthy Adults
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.
Read the 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.
- Conditions
- Healthy Normotensive Volunteers
- Being tested
- Valsartan
- Keywords
- Chronokinetics, chronodynamics, chronopharmacology, valsartan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
Also called Diovan
single oral dose of 160 mg valsartan under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| morning administration | Other | administration of single oral dose valsartan (160 mg) in the morning Receives: Drug: Valsartan |
| evening administration | Other | administration of single oral dose valsartan (160 mg) in the evening Receives: Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Maximum plasma concentration (Cmax),
Measured: blood samples will be collected for 48 hour after drug administration
Pharmacokinetic parameters
Area under the curve (AUC).
Measured: blood samples will be collected for 48 hour after drug administration
Pharmacokinetic parameters
elimination half life (T1/2)
Measured: blood samples will be collected for 48 hour after drug administration
pharmacodynamic parameter
systolic blood pressure (mm Hg) ,diastolic blood pressure (mm Hg)
Measured: Blood samples will be measured at prespecified time points for 48 hour after drug administration
pharmacodynamic parameter
Heart rate (beat/min)
Measured: Blood samples will be measured at prespecified time points for 48 hour after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Normotensive VolunteersStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Osama Mansour, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631031
- Sponsor's protocol ID
- Ph.D (No.26)
- Status last verified
- Aug 2017
- First submitted
- 4 Dec 2015
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Pharmacokinetic and Pharmacodynamic Study of Morning Versus Evening Administration of Valsartan in Healthy Adults
- ClinicalTrials.gov ID
- NCT02631031
- Acronym / sponsor ID
- Ph.D (No.26)
- Conditions
- Healthy Normotensive Volunteers
- Keywords
- Chronokinetics, chronodynamics, chronopharmacology, valsartan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morning administration | Other | Drug: Valsartanadministration of single oral dose valsartan (160 mg) in the morning |
| evening administration | Other | Drug: Valsartanadministration of single oral dose valsartan (160 mg) in the evening |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 including physical examination, laboratory tests.
- Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.
- diurnal active subjects with eight hour night sleep.
Key exclusion criteria (12 listed)
- Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
- Susceptibility to allergic reactions to valsartan.
- Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
- Gastrointestinal diseases.
- Renal diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValsartanAlso: Diovansingle oral dose of 160 mg valsartan under fasting conditions | Drug | evening administration, morning administration |
Primary outcome
Pharmacokinetic parameters
Time frame: blood samples will be collected for 48 hour after drug administration
Maximum plasma concentration (Cmax),
Pharmacokinetic parameters
Time frame: blood samples will be collected for 48 hour after drug administration
Area under the curve (AUC).
Pharmacokinetic parameters
Time frame: blood samples will be collected for 48 hour after drug administration
elimination half life (T1/2)
pharmacodynamic parameter
Time frame: 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)
pharmacodynamic parameter
Time frame: Blood samples will be measured at prespecified time points for 48 hour after drug administration
Heart rate (beat/min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valsartan in people with Healthy Normotensive Volunteers, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters (time frame: blood samples will be collected for 48 hour after drug administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.