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

NCT04577469 | Unknown Phase 1

• 1 other identifier: 827-2018
• Study Type: interventional
• Target: 52
• 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

  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

  12 weeks

Secondary Outcomes (8)

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

  12 weeks

• ECG QTc Interval (safety and tolerability)

  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)

  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)

  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)

  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.

Study Arms (2)

500 mg sulfadoxine / 25 mg pyrimethamine tablet

EXPERIMENTAL

500 mg sulfadoxine / 25 mg pyrimethamine tablet will be administered once.

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.

Drug: Maldox tablets; Drug: G-COSPE® tablets

Interventions

Maldox tablets DRUG

500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition

500 mg sulfadoxine / 25 mg pyrimethamine tablet; G-COSPE® tablets

G-COSPE® tablets DRUG

500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition

500 mg sulfadoxine / 25 mg pyrimethamine tablet; G-COSPE® tablets

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emzor Pharmaceutical Industries Limited: lead

Related Links

• ICH E6(R2) guideline

Study Officials

• Mohammed A Abu Fara, MD,Internist

  ACDIMA Biocenter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabab F Tayyem, PhD

CONTACT

+ 962 79 5616375; rabab@acdima.com

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: February 26, 2020
• First Posted: October 8, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share