Bioequivalence Study of Sulfadoxine/ Pyrimethamine Tablets in Healthy Subjects Under Fasting Conditions
NCT ID: NCT04577469
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
52 participants
INTERVENTIONAL
2020-12-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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500 mg sulfadoxine / 25 mg pyrimethamine tablet
500 mg sulfadoxine / 25 mg pyrimethamine tablet will be administered once.
Maldox 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 to be given as single dose once under fasting condition
G-COSPE® tablets
G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) will be administered once.
Maldox 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 to be given as single dose once under fasting condition
Interventions
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Maldox 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 to be given as single dose once under fasting condition
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
ALL
Yes
Sponsors
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Emzor Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Mohammed A Abu Fara, MD,Internist
Role: PRINCIPAL_INVESTIGATOR
ACDIMA Biocenter
Central Contacts
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Related Links
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Other Identifiers
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827-2018
Identifier Type: -
Identifier Source: org_study_id
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