BioequivalencePhase 1NCT04577469
Bioequivalence Study of Sulfadoxine/ Pyrimethamine Tablets in Healthy Subjects Under Fasting Conditions
A Phase 1 study testing Maldox tablets and G-COSPE® tablets in people with Bioequivalence, run by Emzor Pharmaceutical Industries Limited.
Trial summary
To asses bio equivalence between two (500 mg sulfadoxine / 25 mg pyrimethamine) formulation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Maldox tablets and G-COSPE® tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Dec 2020
- 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
- The subject is aged between eighteen \& fifty years (18 - 50).
- The subject is within the limits for his height \& weight as defined by the body mass index range (18.5 - 30.0 Kg/m2).
- The subject is willing to undergo the necessary pre- \& post- medical examinations set by this study.
- Results of medical history, vital signs, physical examination \& conducted medical laboratory tests are normal as determined by the clinical investigator.
- The subject tested negative for hepatitis (B \& C) viruses and human immunodeficiency virus (HIV).
- There is no history or evidence of psychiatric disorder, antagonistic personality, and poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
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- The subject is able to understand and willing to sign the informed consent form.
- The subject has normal liver (AST \& ALT enzymes) function.
- The subject's kidney function tests are within normal ranges.
- The subject has normal respiratory system.
- The subject has normal platelet levels.
- For female subjects: negative pregnancy test and the woman is using two reliable contraception methods.
- The subject has normal cardiovascular system, ECG recording \& QTc interval less than 450 ms.
Who cannot join
- The subject is a heavy smoker (more than 10 cigarettes per day).
- The subject has suffered an acute illness one week before dosing.
- The subject has a history of or concurrent consumption of alcohol.
- The subject has a history of or concurrent consumption of illicit drugs.
- The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
- Subject who has been hospitalized within three months before the study or during the study.
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- Subject who is vegetarian.
- The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 23 hours after dosing.
- The subject has taken a prescription medication within two weeks or even an over the counter product (OTC) within one week before dosing and any time during the study, unless otherwise judged acceptable by the clinical investigator.
- The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
- The subjects who have been participating in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the present study
- The subjects who have donated blood within 80 days before first dosing.
- The subject has a history presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized,One-period,Single Oral Dose,Open-label,Parallel,Bioequivalence Study to Compare 500mg Sulfadoxine/25mg Pyrimethamine Tablet Versus G-COSPE® Tablet (500mg Sulfadoxine/25mg Pyrimethamine) in Healthy Subjects Under Fasting Condition
To asses bio equivalence between two (500 mg sulfadoxine / 25 mg pyrimethamine) formulation.
Read the detailed description
The aim of this study is to assess bioequivalence between a single dose from the test product, Sulfadoxine/ Pyrimethamine tablets (500 mg sulfadoxine / 25 mg pyrimethamine), manufactured by Ms. Emzor Pharmaceuticals Industries Ltd, Nigeria versus the reference product G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) manufactured by Guilin Pharmaceutical Co. Ltd, China under fasting conditions and to monitor the safety of the subjects.
- Conditions
- Bioequivalence
- Being tested
- Maldox tablets, G-COSPE® tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maldox tabletsDrug
500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
G-COSPE® tabletsDrug
500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
| Study group | Role | What they receive |
|---|---|---|
| 500 mg sulfadoxine / 25 mg pyrimethamine tablet | Experimental | 500 mg sulfadoxine / 25 mg pyrimethamine tablet will be administered once. Receives: Drug: Maldox tablets; Drug: G-COSPE® tablets |
| G-COSPE® tablets | Active comparator | G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) will be administered once. Receives: Drug: Maldox tablets; Drug: G-COSPE® tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Peak Plasma Concentration (Cmax) for Sulfadoxine and Pyrimethamine.
The average bioequivalence of the products will be concluded if the two-sided 90 % confidence interval for the test to reference ratio of the population means is within 80.00 - 125.00 % for the ln transformed data Cmax of sulfadoxine \& pyrimethamine
Measured: 12 weeks
Area under the plasma concentration versus time curves (AUC0 - 72) for Sulfadoxine and Pyrimethamine.
The average bioequivalence of the products will be concluded if the two-sided 90 % confidence interval for the test to reference ratio of the population means is within 80.00 - 125.00 % for the ln transformed data AUC0 -72 of sulfadoxine \& pyrimethamine
Measured: 12 weeks
Secondary outcomes (8)
Obtaining the Tmax (Time to reach maximum concentration) for Sulfadoxine and Pyrimethamine
The descriptive statistics including Maximum, Minimum and Median values will be measured for Tmax.
Measured: 12 weeks
ECG QTc Interval (safety and tolerability)
Clinically significant abnormal deviations in ECG QTc interval
Measured: ECG recording will be performed 4 hours post- dosing and at the end of the study (at 72.00 hours post dosing) as follow-up tests
Blood pressure (safety and tolerability)
Clinically significant abnormal deviations. Normal range of blood pressure > 90/60 and <140/90 mmHg. Treatment will be offered to those subjects whom blood pressure drops to 90/60 mm Hg or less and the subject will be excluded in case of not responding to treatment.
Measured: At 1-hour pre-dosing; 2, 4, 6, 8, 12 and 23 hours post-dosing (±45 minutes of scheduled time). Blood pressure will also be measured at 48 and 72 hours post-dosing upon ambulatory sample collection.
Pulse (safety and tolerability)
Clinically significant abnormal deviations. Normal range of Pulse 60-100 Bpm.
Measured: At 1-hour pre-dosing; 2, 4, 6, 8, 12 and 23 hours post-dosing (±45 minutes of scheduled time). Pulse will also be measured at 48 and 72 hours post-dosing upon ambulatory sample collection.
Temperature (safety and tolerability)
Clinically significant abnormal deviations. The temperature will be measured axillary, orally or using infrared thermometer, standardized across all subjects. Normal range of temperature 36.5-37.5 ºC.
Measured: At 1-hour pre-dosing; 2, 6, 10, 14, 18, 22 & 23 hours post-dosing (±45 minutes of scheduled time). Temperature will also be measured at 48 and 72 hours post-dosing upon ambulatory sample.
Respiratory rate (safety and tolerability)
Clinically significant abnormal deviations. Normal range of respiratory rate 12-18 B/M
Measured: At 1-hour pre-dosing; 2, 6, 10, 14, 18, 22 & 23 hours post-dosing (±45 minutes of scheduled time). Respiratory rate will also be measured at 48 and 72 hours post-dosing upon ambulatory sample.
Hematology (Safety and Tolerability)
Hematology test will include Complete blood count
Measured: At the end of the study (at 72.00 hours post dosing)
Number of Subjects With AEs
Safety and tolerability: number of subjects with adverse events
Measured: At 12 and 1-hour pre-dosing; 2, 4, 6, 8, 10, 12, 23, 48 and 72 hours post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emzor Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammed A Abu Fara, MD,Internist, Principal investigator, ACDIMA Biocenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577469
- Sponsor's protocol ID
- 827-2018
- Status last verified
- Oct 2020
- First submitted
- 26 Feb 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,One-period,Single Oral Dose,Open-label,Parallel,Bioequivalence Study to Compare 500mg Sulfadoxine/25mg Pyrimethamine Tablet Versus G-COSPE® Tablet (500mg Sulfadoxine/25mg Pyrimethamine) in Healthy Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT04577469
- Acronym / sponsor ID
- 827-2018
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Emzor Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Oct 2020 (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.
To asses bio equivalence between two (500 mg sulfadoxine / 25 mg pyrimethamine) formulation.
Detailed description
The aim of this study is to assess bioequivalence between a single dose from the test product, Sulfadoxine/ Pyrimethamine tablets (500 mg sulfadoxine / 25 mg pyrimethamine), manufactured by Ms. Emzor Pharmaceuticals Industries Ltd, Nigeria versus the reference product G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) manufactured by Guilin Pharmaceutical Co. Ltd, China under fasting conditions and to monitor the safety of the subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 500 mg sulfadoxine / 25 mg pyrimethamine tablet | Experimental | Drug: Maldox tablets, Drug: G-COSPE® tablets500 mg sulfadoxine / 25 mg pyrimethamine tablet will be administered once. |
| G-COSPE® tablets | Active comparator | Drug: Maldox tablets, Drug: G-COSPE® tabletsG-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) will be administered once. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- The subject is aged between eighteen \& fifty years (18 - 50).
- The subject is within the limits for his height \& weight as defined by the body mass index range (18.5 - 30.0 Kg/m2).
- The subject is willing to undergo the necessary pre- \& post- medical examinations set by this study.
- Results of medical history, vital signs, physical examination \& conducted medical laboratory tests are normal as determined by the clinical investigator.
- The subject tested negative for hepatitis (B \& C) viruses and human immunodeficiency virus (HIV).
Key exclusion criteria (13 listed)
- The subject is a heavy smoker (more than 10 cigarettes per day).
- The subject has suffered an acute illness one week before dosing.
- The subject has a history of or concurrent consumption of alcohol.
- The subject has a history of or concurrent consumption of illicit drugs.
- The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
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 |
|---|---|---|
| Maldox tablets500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition | Drug | 500 mg sulfadoxine / 25 mg pyrimethamine tablet, G-COSPE® tablets |
| G-COSPE® tablets500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition | Drug | 500 mg sulfadoxine / 25 mg pyrimethamine tablet, G-COSPE® tablets |
Primary outcome
Bioequivalence based on Peak Plasma Concentration (Cmax) for Sulfadoxine and Pyrimethamine.
Time frame: 12 weeks
The average bioequivalence of the products will be concluded if the two-sided 90 % confidence interval for the test to reference ratio of the population means is within 80.00 - 125.00 % for the ln transformed data Cmax of sulfadoxine \& pyrimethamine
Area under the plasma concentration versus time curves (AUC0 - 72) for Sulfadoxine and Pyrimethamine.
Time frame: 12 weeks
The average bioequivalence of the products will be concluded if the two-sided 90 % confidence interval for the test to reference ratio of the population means is within 80.00 - 125.00 % for the ln transformed data AUC0 -72 of sulfadoxine \& pyrimethamine
8 secondary outcomes
Obtaining the Tmax (Time to reach maximum concentration) for Sulfadoxine and Pyrimethamine
Time frame: 12 weeks
ECG QTc Interval (safety and tolerability)
Time frame: ECG recording will be performed 4 hours post- dosing and at the end of the study (at 72.00 hours post dosing) as follow-up tests
Blood pressure (safety and tolerability)
Time frame: At 1-hour pre-dosing; 2, 4, 6, 8, 12 and 23 hours post-dosing (±45 minutes of scheduled time). Blood pressure will also be measured at 48 and 72 hours post-dosing upon ambulatory sample collection.
Pulse (safety and tolerability)
Time frame: At 1-hour pre-dosing; 2, 4, 6, 8, 12 and 23 hours post-dosing (±45 minutes of scheduled time). Pulse will also be measured at 48 and 72 hours post-dosing upon ambulatory sample collection.
Temperature (safety and tolerability)
Time frame: At 1-hour pre-dosing; 2, 6, 10, 14, 18, 22 & 23 hours post-dosing (±45 minutes of scheduled time). Temperature will also be measured at 48 and 72 hours post-dosing upon ambulatory sample.
Respiratory rate (safety and tolerability)
Time frame: At 1-hour pre-dosing; 2, 6, 10, 14, 18, 22 & 23 hours post-dosing (±45 minutes of scheduled time). Respiratory rate will also be measured at 48 and 72 hours post-dosing upon ambulatory sample.
Hematology (Safety and Tolerability)
Time frame: At the end of the study (at 72.00 hours post dosing)
Number of Subjects With AEs
Time frame: At 12 and 1-hour pre-dosing; 2, 4, 6, 8, 10, 12, 23, 48 and 72 hours post-dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- ICH E6(R2) guidelineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mohammed A Abu Fara, MD,Internist principal investigator
ACDIMA Biocenter
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Maldox tablets and G-COSPE® tablets in people with Bioequivalence, run by Emzor Pharmaceutical Industries Limited.
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 13 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 8 Oct 2020. 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 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 Rabab F Tayyem, PhD (+ 962 79 5616375, rabab@acdima.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence based on Peak Plasma Concentration (Cmax) for Sulfadoxine and Pyrimethamine. (time frame: 12 weeks). 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 8 Oct 2020.