FastingPhase 1NCT06522763
Bioequivalence Study of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet
A Phase 1 study testing Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets. and Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ in people with Fasting, run by Swiss Pharma Nigeria Limited at 1 site in Jordan.
Trial summary
The primary objective of this study is to assess the bioequivalence between the test product and the reference product based on Cmax and AUC0->72 for sulfadoxine and pyrimethamine in healthy adults under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets. and Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteJordan
- Study dates
- Jul 2024to Sep 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects male or female (childbearing potential or surgically sterile female (confirmed by medical/operative report or if medical/operative report is not available by ultrasound test)), age 18 to 50 years, inclusive, for post-menopausal female aged between 45 and 65 years inclusive.
- Body Mass Index (BMI) range8 is within 18.5 - 30.0 Kg/m2.
- Subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs.
- Medical history and physical examination within medically acceptable criteria.
- Subjects having QTc value less than 450 msec for male or less than 440 msec for female at the time of screening.
- Negative pregnancy test or post-menopausal (ie, at least 1 year without menses and without an alternative medical condition prior to the Screening visit, confirmed by FSH test) if female.
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- Laboratory investigations tests within laboratory reference ranges found in Annex I (ALP and creatinine are accepted if below the reference range after being evaluated by the physician as clinically not significant).
- Subject is capable of consent.
- Female subjects of childbearing potential and agrees to use total abstinence or an acceptable contraceptive method of the following: - Systemic contraceptives (birth control pills, injectable/ implantable/ insertable hormonal birth control products, transdermal patch) - Intrauterine device - Condom with intravaginal spermicide
Who cannot join
- Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges
- Presence of any clinically significant results from laboratory tests found in Annex I, however, ALP and creatinine will be accepted if below reference range after being evaluated by the physician as clinically not significant. Laboratory tests are performed not longer than two weeks before the initiation of the clinical study.
- History of drug or alcohol abuse.
- Subject is a heavy smoker (more than 10 cigarettes per day).
- Subject does not agree to not taking any prescription or non-prescription drugs within at least two weeks before study drug administration and until donating the last sample of the study.
- Subject does not agree to not taking any vitamins taken for nutritional purposes within at least two days before study drug administration and until donating the last sample of the study.
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- Subject is on a special diet (for example subject is vegetarian).
- Subject consumes large quantities of alcohol or beverages containing methylxanthines e.g. caffeine (coffee, tea, cola, energy drinks, chocolate etc.).
- Subject does not agree to not consuming any beverages or food containing alcohol at least 48 hours prior to study drug administration until donating the last sample of the study.
- Subject does not agree to not consuming any beverages or food containing methylxanthines e.g. caffeine (coffee, tea, cola, energy drinks, chocolate etc.) at least 24 hours prior to the study drug administration until the end of confinement.
- Subject does not agree to not consuming any beverages or food containing grapefruit at least 7 days prior to study drug administration until donating the last sample of the study.
- Subject has a history of severe diseases, which have direct impact on the study.
- Participation in a bioequivalence study or in a clinical study within the last 90 days before study drug.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
International Pharmaceutical Research Center (IPRC) Queen Rania Street - Sport City Circle,
Amman, 11196
Omaima Omaima Najib, Doctor, +96265627651, o.najib@iprc.com.jo
Nourhan Alramad, Data Analyst, +96265627651, dm@iprc.com.jo
About this study
Official title: Comparative Randomized, Single Dose, Two-Arm, Parallel Open Label Study to Determine the Bioequivalence of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet After an Oral Administration to Healthy Adults Under Fasting Conditions
The primary objective of this study is to assess the bioequivalence between the test product and the reference product based on Cmax and AUC0->72 for sulfadoxine and pyrimethamine in healthy adults under fasting conditions. The secondary objectives of present study are to describe the Tmax and assess the safety and tolerability profile of both test and reference products.
- Conditions
- Fasting
- Being tested
- Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets., Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets.Drug
The 500/25 mg sulfadoxine/pyrimethamine tablet will be dispersed in approximately 10 mL of water in a cup, the mixture obtained will be shaken thoroughly and given immediately to the subject to drink the contents, then the cup will be rinsed with additional approximately 10 mL of water and have the subject drink the contents to assure that the whole dose is taken.
Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQDrug
The 500/25 mg sulfadoxine/pyrimethamine tablet will be dispersed in approximately 10 mL of water in a cup, the mixture obtained will be shaken thoroughly and given immediately to the subject to drink the contents, then the cup will be rinsed with additional approximately 10 mL of water and have the subject drink the contents to assure that the whole dose is taken.
| Study group | Role | What they receive |
|---|---|---|
| Test Product: 500/25mg Sulfadoxine / Pyrimethamine Dispersible tablets. | Experimental | A single oral dose of 500/25 mg sulfadoxine/pyrimethamine dispersible tablets will be administered. Receives: Drug: Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets. |
| Reference Product: SPAQ-CO® Dispersible tablets. | Active comparator | A single oral dose of 500/25 mg sulfadoxine/pyrimethamine dispersible tablet from the SPAQ-CO® will be administered. Receives: Drug: Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Plasma Concentration (Cmax).
The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax are set to be within 80.00-125.00% for sulfadoxine and pyrimethamine. ANOVA using 5 % significance level on logarithmically transformed data (with the 90% confidence intervals) of Cmax and AUC0-72 for sulfadoxine and pyrimethamine using WinNonLin statistical software version 8.4 or higher.
Measured: 72 hours
Area Under the plasma concentration-time Curve (AUC).
The confidence intervals of logarithmically transformed Test/Reference ratios for AUC are set to be within 80.00-125.00% for sulfadoxine and pyrimethamine. ANOVA using 5 % significance level on logarithmically transformed data (with the 90% confidence intervals) of AUC0-72 for sulfadoxine and pyrimethamine using WinNonLin statistical software version 8.4 or higher.
Measured: 72 hours
Secondary outcomes (1)
Time point of maximal plasma concentration (Tmax)
Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.
Measured: To be determined within the 72 hours range
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Pharma Nigeria Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicines for Malaria Venture
- Responsible party
- Sponsor
- Investigators
- Majdi Abu Awida, Doctor, Principal investigator, International Pharmaceutical Research Center ( IPRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522763
- Sponsor's protocol ID
- SUPY-T005
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The access is controlled, with access only after written approval from IPRC.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized, Single Dose, Two-Arm, Parallel Open Label Study to Determine the Bioequivalence of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet After an Oral Administration to Healthy Adults Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06522763
- Acronym / sponsor ID
- SUPY-T005
- Conditions
- Fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Swiss Pharma Nigeria LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Medicines for Malaria Venture
- Study start
- Jul 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 26 Jul 2024 (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 primary objective of this study is to assess the bioequivalence between the test product and the reference product based on Cmax and AUC0->72 for sulfadoxine and pyrimethamine in healthy adults under fasting conditions. The secondary objectives of present study are to describe the Tmax and assess the safety and tolerability profile of both test and reference products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product: 500/25mg Sulfadoxine / Pyrimethamine Dispersible tablets. | Experimental | Drug: Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets.A single oral dose of 500/25 mg sulfadoxine/pyrimethamine dispersible tablets will be administered. |
| Reference Product: SPAQ-CO® Dispersible tablets. | Active comparator | Drug: Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQA single oral dose of 500/25 mg sulfadoxine/pyrimethamine dispersible tablet from the SPAQ-CO® will be administered. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy subjects male or female (childbearing potential or surgically sterile female (confirmed by medical/operative report or if medical/operative report is not available by ultrasound test)), age 18 to 50 years, inclusive, for post-menopausal female aged between 45 and 65 years inclusive.
- Body Mass Index (BMI) range8 is within 18.5 - 30.0 Kg/m2.
- Subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs.
- Medical history and physical examination within medically acceptable criteria.
- Subjects having QTc value less than 450 msec for male or less than 440 msec for female at the time of screening.
Key exclusion criteria (13 listed)
- Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges
- Presence of any clinically significant results from laboratory tests found in Annex I, however, ALP and creatinine will be accepted if below reference range after being evaluated by the physician as clinically not significant. Laboratory tests are performed not longer than two weeks before the initiation of the clinical study.
- History of drug or alcohol abuse.
- Subject is a heavy smoker (more than 10 cigarettes per day).
- Subject does not agree to not taking any prescription or non-prescription drugs within at least two weeks before study drug administration and until donating the last sample of the study.
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 |
|---|---|---|
| Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets.The 500/25 mg sulfadoxine/pyrimethamine tablet will be dispersed in approximately 10 mL of water in a cup, the mixture obtained will be shaken thoroughly and given immediately to the subject to drink the contents, then the cup will be rinsed with additional approximately 10 mL of water and have the subject drink the contents to assure that the whole dose is taken. | Drug | Test Product: 500/25mg Sulfadoxine / Pyrimethamine Dispersible tablets. |
| Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQThe 500/25 mg sulfadoxine/pyrimethamine tablet will be dispersed in approximately 10 mL of water in a cup, the mixture obtained will be shaken thoroughly and given immediately to the subject to drink the contents, then the cup will be rinsed with additional approximately 10 mL of water and have the subject drink the contents to assure that the whole dose is taken. | Drug | Reference Product: SPAQ-CO® Dispersible tablets. |
Primary outcome
Maximal Plasma Concentration (Cmax).
Time frame: 72 hours
The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax are set to be within 80.00-125.00% for sulfadoxine and pyrimethamine. ANOVA using 5 % significance level on logarithmically transformed data (with the 90% confidence intervals) of Cmax and AUC0-72 for sulfadoxine and pyrimethamine using WinNonLin statistical software version 8.4 or higher.
Area Under the plasma concentration-time Curve (AUC).
Time frame: 72 hours
The confidence intervals of logarithmically transformed Test/Reference ratios for AUC are set to be within 80.00-125.00% for sulfadoxine and pyrimethamine. ANOVA using 5 % significance level on logarithmically transformed data (with the 90% confidence intervals) of AUC0-72 for sulfadoxine and pyrimethamine using WinNonLin statistical software version 8.4 or higher.
1 secondary outcome
Time point of maximal plasma concentration (Tmax)
Time frame: To be determined within the 72 hours range
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No. The access is controlled, with access only after written approval from IPRC.
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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.
Majdi Abu Awida, Doctor principal investigator
International Pharmaceutical Research Center ( IPRC)
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 Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets. and Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ in people with Fasting, run by Swiss Pharma Nigeria Limited at 1 site in Jordan.
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 9 inclusion and 13 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 26 Jul 2024. 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 Jordan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yetunde Adigun, B.Pharm (+2349055990983, yetunde.adigun@swiphanigeria.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Plasma Concentration (Cmax). (time frame: 72 hours). The study lists 2 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 26 Jul 2024.