Healthy Normotensive ParticipantsPKVHNCT01767259
Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide
A study testing Valsartan/Hydrochlorothiazide, Valsartan and Hydrochlorothiazide in people with Healthy Normotensive Participants, run by Damanhour University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Normotensive Participants
- What is being tested?
- Valsartan/Hydrochlorothiazide, Valsartan and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2012to Dec 2012
- Phase
- Interventional
- 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
- Men only
- 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
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
Damanhur
About this study
Official title: Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide: An Open-Label, Randomized, Four-Period Crossover Study in Healthy Egyptian Male Volunteers
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.
Read the 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
- Being tested
- Valsartan/Hydrochlorothiazide, Valsartan, Hydrochlorothiazide
- Keywords
- Fixed dose combination, Pharmacokinetics, Valsartan, Hydrochlorothiazide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan/HydrochlorothiazideDrug
Also called Fixed dose combination, Pharmacokinetic interaction
Co-administration or fixed dose combination
ValsartanDrug
Valsartan alone
HydrochlorothiazideDrug
Hydrochlorothiazide alone
| Study group | Role | What they receive |
|---|---|---|
| Valsartan 160 mg alone | Other | Valsartan alone Receives: Drug: Valsartan |
| Hydrochlorothiazide 12.5 mg alone | Other | Hydrochlorothiazide alone Receives: Drug: Hydrochlorothiazide |
| Valsartan160 mg + Hydrochlorothiazide12.5 mg | Other | Concomitant administration of valsartan 160 mg + Hydrochlorothiazide 12.5 mg Receives: Drug: Valsartan/Hydrochlorothiazide |
| Valsartan / Hydrochlorothiazide 160 mg/12.5mg | Other | Fixed dose combination of valsartan 160 mg + Hydrochlorothiazide 12.5 mg Receives: Drug: Valsartan/Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
Tolerability was assessed based on changes in vital signs (temperature, blood pressure, pulse, and heart rate), measured before dosing in each period and approximately every 4 hours thereafter, and laboratory tests (hematology, biochemistry, liver function, and urinalysis), and performed at baseline and at the end of the study. In addition, a physician questioned volunteers about any adverse events occurring during the study, addressed them as necessary, and recorded them on the appropriate form. This physician was not blinded to treatment, but had no involvement in the study.
Measured: Participants will be followed for the duration of study, an expected average of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Normotensive ParticipantsStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Helmy, PhD, CPHQ, Damanhour University
- Investigators
- Sally Helmy, PhD, CPHQ, Principal investigator, Pharmaceutics Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767259
- Sponsor's protocol ID
- PPT1
- Acronym
- PKVH
- Status last verified
- Jan 2013
- First submitted
- 8 Jan 2013
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide: An Open-Label, Randomized, Four-Period Crossover Study in Healthy Egyptian Male Volunteers
- ClinicalTrials.gov ID
- NCT01767259
- Acronym / sponsor ID
- PKVH / PPT1
- Conditions
- Healthy Normotensive Participants
- Keywords
- Fixed dose combination, Pharmacokinetics, Valsartan, Hydrochlorothiazide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Jan 2013 (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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Valsartan 160 mg alone | Other | Drug: ValsartanValsartan alone |
| Hydrochlorothiazide 12.5 mg alone | Other | Drug: HydrochlorothiazideHydrochlorothiazide alone |
| Valsartan160 mg + Hydrochlorothiazide12.5 mg | Other | Drug: Valsartan/HydrochlorothiazideConcomitant administration of valsartan 160 mg + Hydrochlorothiazide 12.5 mg |
| Valsartan / Hydrochlorothiazide 160 mg/12.5mg | Other | Drug: Valsartan/HydrochlorothiazideFixed dose combination of valsartan 160 mg + Hydrochlorothiazide 12.5 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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
- 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.
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Valsartan/HydrochlorothiazideAlso: Fixed dose combination, Pharmacokinetic interactionCo-administration or fixed dose combination | Drug | Valsartan / Hydrochlorothiazide 160 mg/12.5mg, Valsartan160 mg + Hydrochlorothiazide12.5 mg |
| ValsartanValsartan alone | Drug | Valsartan 160 mg alone |
| HydrochlorothiazideHydrochlorothiazide alone | Drug | Hydrochlorothiazide 12.5 mg alone |
Primary outcome
Tolerability
Time frame: Participants will be followed for the duration of study, an expected average of 6 weeks.
Tolerability was assessed based on changes in vital signs (temperature, blood pressure, pulse, and heart rate), measured before dosing in each period and approximately every 4 hours thereafter, and laboratory tests (hematology, biochemistry, liver function, and urinalysis), and performed at baseline and at the end of the study. In addition, a physician questioned volunteers about any adverse events occurring during the study, addressed them as necessary, and recorded them on the appropriate form. This physician was not blinded to treatment, but had no involvement in the study.
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 15 Jan 2013.
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.
Sally Helmy, PhD, CPHQ principal investigator
Pharmaceutics Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valsartan/Hydrochlorothiazide, Valsartan and Hydrochlorothiazide in people with Healthy Normotensive Participants, run by Damanhour 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 5 inclusion and 10 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 15 Jan 2013. 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.
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?
Tolerability (time frame: Participants will be followed for the duration of study, an expected average of 6 weeks.). 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 15 Jan 2013.