EVALUATION OF PHARMACOKINETICS (FATE OF DRUG IN THE BODY) OF SINGLE DOSE PRIMAQUINE (15 mg) IN PATIENTS WITH LIVER DYSFUNCTION

EVALUATION OF PHARMACOKINETICS OF SINGLE DOSE PRIMAQUINE (15 mg) IN PATIENTS WITH HEPATIC DYSFUNCTION - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/06/001794

Enrollment

Registered

2011-06-09

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- Patients with mild to moderate hepatic dysfunction (Modified Child-Pugh score 5-9)

Interventions

Intervention1: T. Primaquine: 15 mg single oral dose Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants classified by the Modified Child-Pugh Classification as having Grade A (mild) (Score of 5-6) or Grade B (moderate)(Score7-9) hepatic impairment 2. Participants with Normal Renal profile 3. Peripheral smear negative for malarial parasite 4. Willing to give written Informed Consent & comply with protocol requirement

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 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. Participants having WBC count of less than 3000/cmm 5. Any gastrointestinal disorder like diarrhea, constipation within 7 days before enrollment 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 (even if a pregnant woman is G6PD normal, the fetus may not be) & breast feeding women 10. Participants of Arthritis, Psoriasis, SLE, DLE 11. History of surgical portosystemic shunt.

Design outcomes

Primary

Measure	Time frame
tmax, CMax, AUC0-t, AUC0-â??, Vd and t1/2 of PrimaquineTimepoint: 0 h (predosing) and 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10, 11, 12 and 24 h post dosing	—

Secondary

Measure	Time frame
Safety of Primaquine 15 mg single oral dose in patients with hepatic dysfunctionTimepoint: Throughout the study and at 24 hours postdose	—

Countries

India

Contacts

Public ContactDr Nithya Gogtay

NIL

njgogtay@hotmail.com91-22-24174420

Outcome results

None listed

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