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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. The subject is aged between eighteen & fifty years (18 - 50).
  2. The subject is within the limits for his height & weight as defined by the body mass index range (18.5 - 30.0 Kg/m2).
  3. The subject is willing to undergo the necessary pre- & post- medical examinations set by this study.
  4. Results of medical history, vital signs, physical examination & conducted medical laboratory tests are normal as determined by the clinical investigator.
  5. The subject tested negative for hepatitis (B & C) viruses and human immunodeficiency virus (HIV).
  6. 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.
  7. The subject is able to understand and willing to sign the informed consent form.
  8. The subject has normal liver (AST & ALT enzymes) function.
  9. The subject's kidney function tests are within normal ranges.
  10. The subject has normal respiratory system.
  11. The subject has normal platelet levels.
  12. For female subjects: negative pregnancy test and the woman is using two reliable contraception methods.
  13. The subject has normal cardiovascular system, ECG recording & QTc interval less than 450 ms.

Exclusion criteria:

  1. The subject is a heavy smoker (more than 10 cigarettes per day).
  2. The subject has suffered an acute illness one week before dosing.
  3. The subject has a history of or concurrent consumption of alcohol.
  4. The subject has a history of or concurrent consumption of illicit drugs.
  5. The subject has a history of hypersensitivity and/or contraindications to the study drug and any related compounds.
  6. Subject who has been hospitalized within three months before the study or during the study.
  7. Subject who is vegetarian.
  8. The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 23 hours after dosing.
  9. 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.
  10. The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before first dosing and any time during the study.
  11. 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
  12. The subjects who have donated blood within 80 days before first dosing.
  13. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 500 mg sulfadoxine / 25 mg pyrimethamine tablet
500 mg sulfadoxine / 25 mg pyrimethamine tablet will be administered once.
Drug: Maldox tablets
500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
Drug: G-COSPE® tablets
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.
Drug: Maldox tablets
500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
Drug: G-COSPE® tablets
500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emzor Pharmaceutical Industries Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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