A study of a new primaquine 5 mg formulation in healthy volunteers

Phase 1

• Conditions: Vivax malaria; C01.610.752.530.700 C01.920.875.700

• Registration Number: RBR-105nyj86
• Lead Sponsor: Fundação Oswaldo Cruz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-23
• Study Start: 2021-06-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Men,
Non-pregnant and non-breastfeeding women
Within the age range 18 to 50 years old
Body Mass index range 19 to 28,5 Kg/m2
Health volunteers
Signed Informed Consent

Exclusion Criteria

Hypersensibility to the drug (primaquine): Previous pathologies that could influence the absorption distribution or excretion of the drug; Positive G6PD deficiency quantitative or pregnancy test. Use o concomitant medicines; Any clinical or laboratory exam abnormality;
Smokers; heavy coffee drinkers (>5 cups/Day); Abusive alcohol use: use of any treatment within 2 weeks before the study;Any previous hospitalization with 8 weeks before the study: Any previous treatment with known drug interaction with the test drug within 03 months; Blood donation greater than 450ml 03 months prior the study, or 1500ml in the previous 12 months; Use of Cyp 450 Inductors medications 4 weeks prior; Consume of alcohol or grapefruit 48h prior hospitalization;

Study & Design

• Study Type: Intervention
• Study Design: Not specified