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

Emzor Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Bioequivalence

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04577469

827-2018

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

500 mg sulfadoxine / 25 mg pyrimethamine tablet

Experimental group

Description:

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

Treatment:

Drug: Maldox tablets

Drug: G-COSPE® tablets

G-COSPE® tablets

Active Comparator group

Description:

G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) will be administered once.

Treatment:

Drug: Maldox tablets

Drug: G-COSPE® tablets