Skip to content

A clinical trial to evaluate the pharmacokinetics of single dose primaquine (15mg) in patients with renal dysfunction

Evaluation of pharmacokinetics of single dose primaquine (15mg) in patients with renal dysfunction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000356
Enrollment
24
Registered
2010-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic renal failure

Interventions

Intervention1: Primaquine: 15mg single dose Intervention2: Primaquine: 15mg single dose Control Intervention1: NA: NA Control Intervention2: NA: NA

Sponsors

Self funded
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject of either gender 2. Age between 18-60 years 3. Subjects classified by NKF-KDOQI guidelines Group 1: 15.29ml/mns/1.73sq.mt, Group 2:

Exclusion criteria

Exclusion criteria: 1. Participation in any clinical trial or investigational new drug study within 4 weeks prior to dosing 2. Donation or loss of 300ml or more of blood within 8 weeks prior to study start 3. History of asthma and chronic obstructive pulmonary disease, treated or not treated or clinically significant drug allergy, history of atopic allergy (asthma, utricaria, eczematous dermatitis) 4. Peripheral smear positive for malarial parasite 5. Any gastrointestinal disorder like diarrhea, constipation within 7 days 6. G6PD deficiency 7. Known hypersensitivity to primaquine or related drugs (e.g. iodoquinol) as per history taking 8. Persons receiving treatment with other potentially hemolytic drugs 9. Pregnancy and breast feeding 10. History of surgical portosytemic shunt

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic of primaquineTimepoint: NA

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactDr. Nithya Gogtay
njgogtay@hotmail.com02224174420

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026