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

Phase 4

• Conditions: Health Condition 1: null- Patients with mild to moderate hepatic dysfunction (Modified Child-Pugh score 5-9)

• Registration Number: CTRI/2011/06/001794
• Lead Sponsor: I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 24

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified