PharmacogenomicsPhase 4UGT/PKsNCT05294484
Effect of Genetic Polymorphisms of UGT on the PKs of Indapamide in Egyptians
A Phase 4 study testing Indapamide 1.5 MG SR in people with Pharmacogenomics, run by Ain Shams University.
Trial summary
The aim of this works is to investigate the effect of genetic variation of UGT2B7 on human response to treatment with indapamide and its correlation with pharmacokinetic parameters in Egyptian subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacogenomics
- What is being tested?
- Indapamide 1.5 MG SR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2022to 1 Oct 2022
- Phase
- Phase 4
- 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
- Subjects should be healthy adult volunteers with age between (18-45) with normal body weight.
- The volunteers will be asked to provide a complete medical history, and complete a physical examination, laboratory tests (hematology, clinical chemistry, urinalysis, serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihuman immunodeficiency virus antibody)
Who cannot join
- Treatment with any known enzyme -inducing /inhibiting agent within 30 days prior to the start of the study and throughout the study.
- Subjects who have taken any medication less than two weeks of the trials starting date
- Susceptibility to allergic reaction to study drugs
- Any prior surgery of the gastrointestinal tract that may interfere with drug absorption
- Gastrointestinal diseases
- Renal diseases
Show all 11Show fewer
- Pancreatic disease including diabetes
- Hepatic diseases
- Hematological diseases or pulmonary diseases
- Abnormal laboratory values
- Subject 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the Effect of Genetic Polymorphisms of Uridine Diphosphate Glucuronosyl Transferase (UGT) on the Pharmacokinetics of Indapamide in Egyptians
The aim of this works is to investigate the effect of genetic variation of UGT2B7 on human response to treatment with indapamide and its correlation with pharmacokinetic parameters in Egyptian subjects.
Read the detailed description
Indapamide is a thiazide-type diuretic commonly prescribed to treat mild to moderate hypertension. As it has fewer side effects in inducing metabolic derangements than other thiazide diuretics, indapamide is well accepted to be used as initial therapy to treat hypertension in patients with previous stroke or older people (over 80) or as an add-on treatment. However, severe hyponatremia and hypokalemia have been reported. Therefore, limiting the dose to that necessary to achieve maximal blood pressure reduction and improved cardiovascular outcomes is relevant. Although the major metabolites of indapamide have been identified, the pathways of cytochrome P450 (CYP450)-catalyzed indapamide biotransformation have not been fully elucidated. One recent report suggested that CYP2C19, CYP2C8, and CYP3A4 are involved in the metabolism. Recent advancement in the field of glucuronidation has identified a high degree of allelic diversity for human uridine diphosphate glucuronosyl transferases (UGTs).
As indapamide is glucuronidated by UGT enzymes, poly-morphisms in the genes encoding these drug-metabolizing enzymes could potentially influence its PK. Large inter-individual variability in the rate of glucuronidation of various drugs has been reported. The UGT2B7 enzyme is expressed in the liver and many extrahepatic tissues. Mutations in the UGT2B7 gene may therefore have pharmacological, toxicological, and physiological significance.
the investigators have little information on pharmacogenetics (PG) studies of indapamide. The effect of genetic variation on DMEs activity and the clinical impact on indapamide in particular are not fully understood.
The ultimate goal of personalized medicine is to identify specific genetic features with the differential risk of human diseases or the efficacy of certain therapeutic interventions . Mounting evidence has linked the genetic make-up to a significant portion of drug-induced toxicity. The primary focus of PG is DMEs activity.
The pharmacology of drugs subject to inherited variability in metabolism is often complex. Few have simple or single pathway of elimination. In addition, ethnicity may account for the observed differences in both pharmacokinetics (PK) and pharmacodynamics of drugs, thus resulting in variability in response to drug therapy. Furthermore, genetic polymorphism is one of the most important factors that may contribute to the ethnic sensitivity of a drug in its metabolic pathways.
Single nucleotide polymorphism (SNP) is the most frequently observed mutation in all organisms. The cost for mapping of the genetic variance among thousands of SNPs could be extremely high. Recent advances in whole-genome sequencing (WGS) have led to burst of bioinformation and a significant knowledge base for investigating the genetic architecture of drug metabolisms and treatment efficacies.
- Conditions
- Pharmacogenomics
- Being tested
- Indapamide 1.5 MG SR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indapamide 1.5 MG SRDrug
the effect of genetic variation of UGT2B7 on human response to treatment with indapamide and its correlation with pharmacokinetic parameters in Egyptian subjects
| Study group | Role | What they receive |
|---|---|---|
| Fasting group | Active comparator | Following an overnight fast of at least 10 hours, subjects should be administered single dose of indapamide 1.5 mg SR with 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired except for one hour before and after drug administration. Subjects should receive standardized meals scheduled at the same time in each period of the study. Receives: Drug: Indapamide 1.5 MG SR |
| Fed group | Active comparator | Following an overnight fast of at least 10 hours, subjects should start the recommended meal 30 minutes prior to administration of the drug. Study subjects should eat this meal in 30 minutes or less; however, indapamide 1.5 mg SR should be administered 30 minutes after start of the meal. The drug should be administered with 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired except for one hour before and after drug administration. Subjects should receive standardized meals scheduled at the same time in each period of the study.
All subjects should abstain from the consumption of fruit juices during the study period. All the subjects are to be under complete medical supervision. Receives: Drug: Indapamide 1.5 MG SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
the PK parameters of Indapamide following single oral dose include:
area under the concentration-time curve over the dosing interval (AUC[0-tau])
Measured: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
maximum concentration (Cmax)
maximum concentration (Cmax)
Measured: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
time of occurrence of Cmax (Tmax)
time of occurrence of Cmax (Tmax)
Measured: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
terminal phase half-life (T1/2)
terminal phase half-life (T1/2)
Measured: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
clearance
clearance
Measured: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
volume of distribution
volume of distribution
Measured: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
Detection of UGT2B7 SNPs (rs 7438135, rs 11740316) (genetic variation in Egyptian population)
Samples will be collected from each subject into tubes and stored at -80°C, Genomics DNA will be isolated according to manufactures instructions. Polymorphisms will be assessed using suitable recommended assay.
Measured: 6 months
Secondary outcomes (3)
Vital sign measurement following single dose administration as a measure of safety and tolerability
Vital sign measurements will include systolic and diastolic blood pressure
Measured: every month up to 6 months
pulse rate
pulse rate
Measured: up to 6 months
body temperature
body temperature measurement
Measured: up to 6-7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start15 Mar 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PharmacogenomicsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A comparative randomized, single-dose, two-treatment (fed vs. fasting), parallel design of indapamide in healthy adult Egyptions
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nagwa A. Sabri, professor, Study chair, Department of Clinical Pharmacy, Faculty of Pharmacy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294484
- Sponsor's protocol ID
- PG/PK Study on Indapamide
- Acronym
- UGT/PKs
- Status last verified
- Dec 2021
- First submitted
- 10 Aug 2021
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reilly RF, Peixoto AJ, Desir GV. The evidence-based use of thiazide diuretics in hypertension and nephrolithiasis. Clin J Am Soc Nephrol. 2010 Oct;5(10):1893-903. doi: 10.2215/CJN.04670510. Epub 2010 Aug 26.
PubMed 20798254Psaty BM, Smith NL, Siscovick DS, Koepsell TD, Weiss NS, Heckbert SR, Lemaitre RN, Wagner EH, Furberg CD. Health outcomes associated with antihypertensive therapies used as first-line agents. A systematic review and meta-analysis. JAMA. 1997 Mar 5;277(9):739-45.
PubMed 9042847Campbell DB, Phillips EM. Short term effects and urinary excretion of the new diuretic, indapamide, in normal subjects. Eur J Clin Pharmacol. 1974 Oct 4;7(6):407-14. doi: 10.1007/BF00560352. No abstract available.
PubMed 4612998Wang TH, Hsiong CH, Ho HT, Shih TY, Yen SJ, Wang HH, Wu JY, Kuo BP, Chen YT, Ho ST, Hu OY. Genetic polymorphisms of metabolic enzymes and the pharmacokinetics of indapamide in Taiwanese subjects. AAPS J. 2014 Mar;16(2):206-13. doi: 10.1208/s12248-013-9535-x. Epub 2013 Dec 20.
PubMed 24357089
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Genetic Polymorphisms of Uridine Diphosphate Glucuronosyl Transferase (UGT) on the Pharmacokinetics of Indapamide in Egyptians
- ClinicalTrials.gov ID
- NCT05294484
- Acronym / sponsor ID
- UGT/PKs / PG/PK Study on Indapamide
- Conditions
- Pharmacogenomics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 24 Mar 2022 (actual)
- 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 aim of this works is to investigate the effect of genetic variation of UGT2B7 on human response to treatment with indapamide and its correlation with pharmacokinetic parameters in Egyptian subjects.
Detailed description
Indapamide is a thiazide-type diuretic commonly prescribed to treat mild to moderate hypertension. As it has fewer side effects in inducing metabolic derangements than other thiazide diuretics, indapamide is well accepted to be used as initial therapy to treat hypertension in patients with previous stroke or older people (over 80) or as an add-on treatment. However, severe hyponatremia and hypokalemia have been reported. Therefore, limiting the dose to that necessary to achieve maximal blood pressure reduction and improved cardiovascular outcomes is relevant. Although the major metabolites of indapamide have been identified, the pathways of cytochrome P450 (CYP450)-catalyzed indapamide biotransformation have not been fully elucidated. One recent report suggested that CYP2C19, CYP2C8, and CYP3A4 are involved in the metabolism. Recent advancement in the field of glucuronidation has identified a high degree of allelic diversity for human uridine diphosphate glucuronosyl transferases (UGTs).
As indapamide is glucuronidated by UGT enzymes, poly-morphisms in the genes encoding these drug-metabolizing enzymes could potentially influence its PK. Large inter-individual variability in the rate of glucuronidation of various drugs has been reported. The UGT2B7 enzyme is expressed in the liver and many extrahepatic tissues. Mutations in the UGT2B7 gene may therefore have pharmacological, toxicological, and physiological significance.
the investigators have little information on pharmacogenetics (PG) studies of indapamide. The effect of genetic variation on DMEs activity and the clinical impact on indapamide in particular are not fully understood.
The ultimate goal of personalized medicine is to identify specific genetic features with the differential risk of human diseases or the efficacy of certain therapeutic interventions . Mounting evidence has linked the genetic make-up to a significant portion of drug-induced toxicity. The primary focus of PG is DMEs activity.
The pharmacology of drugs subject to inherited variability in metabolism is often complex. Few have simple or single pathway of elimination. In addition, ethnicity may account for the observed differences in both pharmacokinetics (PK) and pharmacodynamics of drugs, thus resulting in variability in response to drug therapy. Furthermore, genetic polymorphism is one of the most important factors that may contribute to the ethnic sensitivity of a drug in its metabolic pathways.
Single nucleotide polymorphism (SNP) is the most frequently observed mutation in all organisms. The cost for mapping of the genetic variance among thousands of SNPs could be extremely high. Recent advances in whole-genome sequencing (WGS) have led to burst of bioinformation and a significant knowledge base for investigating the genetic architecture of drug metabolisms and treatment efficacies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A comparative randomized, single-dose, two-treatment (fed vs. fasting), parallel design of indapamide in healthy adult Egyptions
| Arm | Type | Receives |
|---|---|---|
| Fasting group | Active comparator | Drug: Indapamide 1.5 MG SRFollowing an overnight fast of at least 10 hours, subjects should be administered single dose of indapamide 1.5 mg SR with 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired except for one hour before and after drug administration. Subjects should receive standardized meals scheduled at the same time in each period of the study. |
| Fed group | Active comparator | Drug: Indapamide 1.5 MG SRFollowing an overnight fast of at least 10 hours, subjects should start the recommended meal 30 minutes prior to administration of the drug. Study subjects should eat this meal in 30 minutes or less; however, indapamide 1.5 mg SR should be administered 30 minutes after start of the meal. The drug should be administered with 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired except for one hour before and after drug administration. Subjects should receive standardized meals scheduled at the same time in each period of the study. All subjects should abstain from the consumption of fruit juices during the study period. All the subjects are to be under complete medical supervision. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects should be healthy adult volunteers with age between (18-45) with normal body weight.
- The volunteers will be asked to provide a complete medical history, and complete a physical examination, laboratory tests (hematology, clinical chemistry, urinalysis, serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihuman immunodeficiency virus antibody)
Key exclusion criteria (11 listed)
- Treatment with any known enzyme -inducing /inhibiting agent within 30 days prior to the start of the study and throughout the study.
- Subjects who have taken any medication less than two weeks of the trials starting date
- Susceptibility to allergic reaction to study drugs
- Any prior surgery of the gastrointestinal tract that may interfere with drug absorption
- Gastrointestinal 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 |
|---|---|---|
| Indapamide 1.5 MG SRthe effect of genetic variation of UGT2B7 on human response to treatment with indapamide and its correlation with pharmacokinetic parameters in Egyptian subjects | Drug | Fasting group, Fed group |
Primary outcome
the PK parameters of Indapamide following single oral dose include:
Time frame: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
area under the concentration-time curve over the dosing interval (AUC[0-tau])
maximum concentration (Cmax)
Time frame: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
maximum concentration (Cmax)
time of occurrence of Cmax (Tmax)
Time frame: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
time of occurrence of Cmax (Tmax)
terminal phase half-life (T1/2)
Time frame: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
terminal phase half-life (T1/2)
clearance
Time frame: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
clearance
volume of distribution
Time frame: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration
volume of distribution
Detection of UGT2B7 SNPs (rs 7438135, rs 11740316) (genetic variation in Egyptian population)
Time frame: 6 months
Samples will be collected from each subject into tubes and stored at -80°C, Genomics DNA will be isolated according to manufactures instructions. Polymorphisms will be assessed using suitable recommended assay.
3 secondary outcomes
Vital sign measurement following single dose administration as a measure of safety and tolerability
Time frame: every month up to 6 months
pulse rate
Time frame: up to 6 months
body temperature
Time frame: up to 6-7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Background: PubMed 20798254Reilly RF, Peixoto AJ, Desir GV. The evidence-based use of thiazide diuretics in hypertension and nephrolithiasis. Clin J Am Soc Nephrol. 2010 Oct;5(10):1893-903. doi: 10.2215/CJN.04670510. Epub 2010 Aug 26.
- Background: PubMed 9042847Psaty BM, Smith NL, Siscovick DS, Koepsell TD, Weiss NS, Heckbert SR, Lemaitre RN, Wagner EH, Furberg CD. Health outcomes associated with antihypertensive therapies used as first-line agents. A systematic review and meta-analysis. JAMA. 1997 Mar 5;277(9):739-45.
- Background: PubMed 4612998Campbell DB, Phillips EM. Short term effects and urinary excretion of the new diuretic, indapamide, in normal subjects. Eur J Clin Pharmacol. 1974 Oct 4;7(6):407-14. doi: 10.1007/BF00560352. No abstract available.
- Background: PubMed 24357089Wang TH, Hsiong CH, Ho HT, Shih TY, Yen SJ, Wang HH, Wu JY, Kuo BP, Chen YT, Ho ST, Hu OY. Genetic polymorphisms of metabolic enzymes and the pharmacokinetics of indapamide in Taiwanese subjects. AAPS J. 2014 Mar;16(2):206-13. doi: 10.1208/s12248-013-9535-x. Epub 2013 Dec 20.
Related trials for Pharmacogenomics
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruitingPhase 4
Investigating a Personalized Approach to Anti-Platelet Therapy
High Risk Bleeding
Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
RecruitingObservational study
Avera Cancer Sequencing and Analytics Protocol (ASAP)
Cancer, Cancer Diagnosis
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.
Nagwa A. Sabri, professor study chair
Department of Clinical Pharmacy, Faculty of Pharmacy, Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indapamide 1.5 MG SR in people with Pharmacogenomics, run by Ain Shams University.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal A Elkholy, PhD (+201060355448, amalanas9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the PK parameters of Indapamide following single oral dose include: (time frame: at Day 0: prior to drug administration (blank), then samples (5ml each) will be obtained at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, and 24 hour after drug administration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294484, which also lists 4 linked publications.
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 24 Mar 2022.