Bioequivalence Study of Sulfadoxine/ Pyrimethamine Dispersible Tablets in Healthy Subjects Under Fasting Conditions

NCT05497063 | Unknown Phase 1

• 1 other identifier: 1100-2021
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

To asses bio equivalence between two (500 mg sulfadoxine / 25 mg pyrimethamine) formulation

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (2)

• 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

  72 hours

• 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

  72 hours

Secondary Outcomes (7)

• Obtaining the Tmax (Time to reach maximum concentration) for Sulfadoxine and Pyrimethamine

  72 hours

• Number of participant with treatment related adverse events as assessed by CTCAE v4.0.

  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

• Number of participant with treatment related adverse events as assessed by CTCAE v4.0.

  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.

• Number of participant with treatment related adverse events as assessed by CTCAE v4.0.

  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.

• Number of participant with treatment related adverse events as assessed by CTCAE v4.0.

  At 1-hour pre-dosing; 2, 6, 10, 14, 18, 22 & 23 hours postdosing (±45 minutes of scheduled time).Temperature will also be measured at 48 and 72 hours post-dosing upon ambulatory sample.

Study Arms (2)

Sulfadoxine/Pyrimethamine dispersible tablets, 250 mg sulfadoxine / 12.5 mg pyrimethamine

EXPERIMENTAL

Two dispersible tablets of Sulfadoxine/Pyrimethamine (250 mg sulfadoxine / 12.5 mg pyrimethamine to be given as single dose once under fasting condition

Drug: Sulfadoxine/Pyrimethamine dispersible tablets, 250 mg sulfadoxine / 12.5 mg pyrimethamine & 500 mg sulfadoxine / 25 mg pyrimethamine

G-COSPE® tablets, 500 mg sulfadoxine / 25 mg pyrimethamine

ACTIVE COMPARATOR

One tablet of G-COSPE® tablets, 500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition

Drug: G-COSPE® tablets

Interventions

Sulfadoxine/Pyrimethamine dispersible tablets, 250 mg sulfadoxine / 12.5 mg pyrimethamine & 500 mg sulfadoxine / 25 mg pyrimethamine DRUG

Two tablets of 250 mg sulfadoxine / 12.5 mg pyrimethamine or 500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition

Sulfadoxine/Pyrimethamine dispersible tablets, 250 mg sulfadoxine / 12.5 mg pyrimethamine

G-COSPE® tablets DRUG

One tablet of G-COSPE® tablets, 500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition

G-COSPE® tablets, 500 mg sulfadoxine / 25 mg pyrimethamine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. The subject is Caucasian \& aged between eighteen \& fifty years (18 - 50), both inclusive.
• \. The subject is within the limits for his/her 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 per appendix 3.
• \. 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. 9. The subject's kidney function tests are within normal ranges. As per appendix 3.
• \. The subject has normal respiratory system. 11. The subject's folic acid levels are within normal range. 12. The subject has normal platelet levels. As per appendix 3. 13. For female subjects: negative pregnancy test and the woman is using two reliable contraception methods during the study and until 52 days after dosing.
• Note: Pyrimethamine/sulfadoxine showed reproductive toxicity in animal studies. Pyrimethamine/sulfadoxine should not be used during the first trimester of pregnancy unless the benefit is considered to outweigh the risks and alternative drugs are not available. During 2nd or 3rd trimesters of pregnancy, may be used for intermittent preventive treatment in pregnancy.
• \. The subject has normal cardiovascular system, ECG recording \& QTc interval less than 450 ms.

You may not qualify if:

• \. 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.
• \. Subject who has been hospitalized within three months before the study or during the study.
• \. Subject who is vegetarian. 8. The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days before dosing and until 72 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 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 12. The subjects who have donated blood within 80 days before first dosing. 13. The subject has a history of G6PD Deficiency. 14. The subject has a history presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or psychiatric diseases.

Sponsors & Collaborators

• Emzor Pharmaceutical Industries Limited: lead

MeSH Terms

Interventions

Sulfadoxine; Pyrimethamine

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: August 11, 2022
• Study Start: December 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share