Pharmacokinetics of primaquine in hepatic dysfunction patient

Evaluation the single dose and steady state pharmacokinetics of 15mg primaquine in patients moderate hepatic dysfunction in comparison with normal healthy volunteers.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/06/003760

Enrollment

Registered

2013-06-17

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- Moderate Hepatic dysfunction vs healthy volunteers

Interventions

Intervention1: Tablet Primaquine: Tablet Primaquine 15 mg per day, orally for 4 days Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Will determine the pharmacokinetics of primaquine in hepatic dysfunction patientTimepoint: NA	—

Secondary

Measure	Time frame
1. To compare the primaquine kinetics of moderate hepatic dysfunction patient to healthy volunteers 2. To evaluate whether 15mg primaquine is safe in patient with hepatic dysfunction.Timepoint: Not applicable	—

Countries

India

Contacts

Public ContactDr Nithya Gogtay

Seth G S Medical College and KEM Hospital

njgogtay@hotmail.com02224174420

Outcome results

None listed

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