- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04577469
Bioequivalence Study of Sulfadoxine/ Pyrimethamine Tablets in Healthy Subjects Under Fasting Conditions
October 6, 2020 updated by: Emzor Pharmaceutical Industries Limited
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rabab F Tayyem, PhD
- Phone Number: + 962 79 5616375
- Email: rabab@acdima.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- 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.
- 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.
Exclusion criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 500 mg sulfadoxine / 25 mg pyrimethamine tablet
500 mg sulfadoxine / 25 mg pyrimethamine tablet will be administered once.
|
500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
|
Active Comparator: G-COSPE® tablets
G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) will be administered once.
|
500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obtaining the Tmax (Time to reach maximum concentration) for Sulfadoxine and Pyrimethamine
Time Frame: 12 weeks
|
The descriptive statistics including Maximum, Minimum and Median values will be measured for Tmax.
|
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
|
Clinically significant abnormal deviations in ECG QTc interval
|
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.
|
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.
|
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.
|
Clinically significant abnormal deviations.
Normal range of Pulse 60-100 Bpm.
|
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.
|
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.
|
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.
|
Clinically significant abnormal deviations.
Normal range of respiratory rate 12-18 B/M
|
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)
|
Hematology test will include Complete blood count
|
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
|
Safety and tolerability: number of subjects with adverse events
|
At 12 and 1-hour pre-dosing; 2, 4, 6, 8, 10, 12, 23, 48 and 72 hours post-dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mohammed A Abu Fara, MD,Internist, ACDIMA Biocenter
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2020
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
February 26, 2020
First Submitted That Met QC Criteria
September 30, 2020
First Posted (Actual)
October 8, 2020
Study Record Updates
Last Update Posted (Actual)
October 8, 2020
Last Update Submitted That Met QC Criteria
October 6, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 827-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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