Pharmacokinetics of primaquine in hepatic dysfunction patient
- Conditions
- Health Condition 1: null- Moderate Hepatic dysfunction vs healthy volunteers
- Registration Number
- CTRI/2013/06/003760
- Lead Sponsor
- Investigator initiated study
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 24
For patients:
1. Participants classified by the Modified Child-Pugh Classification as having Grade B (Score7-9) hepatic impairment (Mild ascitis, S.albumin- 2.8-3.5, S.bilirubin-2-3, Prothrombin time-1.8-2.3 INR, Hepatic encephalopathy-Grade 1-2)
2. Participants with Normal Renal profile
3. Peripheral smear negative for malarial parasite
4. Willing to give written Informed Consent & comply with protocol requirement.
For healthy volunteers:
1. Normal hematology, biochemistry and urine analysis
2. Negative for HIV and HBsAg
3. Peripheral smear negative for malarial parasite
4. Willing to give written Informed Consent & comply with protocol requirement.
For patients and healthy volunteers
1.Participation in any clinical trial or investigational new drug study within 4 weeks prior to dosing.
2.Donation or loss of 300 mL 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, urticaria, eczematous dermatitis.
4.G6PD deficiency.
5.Known hypersensitivity to primaquine or related drugs (e.g., iodoquinol) as per history taking.
6.Persons receiving treatment with other potentially hemolytic drugs.
7.Pregnancy (even if a pregnant woman is G6PD normal, the fetus may not be) & breast feeding women.
8.Participants of Arthritis, Psoriasis, SLE, DLE.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Will determine the pharmacokinetics of primaquine in hepatic dysfunction patientTimepoint: NA
- Secondary Outcome Measures
Name Time Method 1. To compare the primaquine kinetics of moderate hepatic dysfunction patient to healthy volunteers <br/ ><br>2. To evaluate whether 15mg primaquine is safe in patient with hepatic dysfunction.Timepoint: Not applicable