A study on pharmacokinetics (fate of drug in the body) of single oral dose of 15mg and 45 mg Primaquine in healthy human volunteers

A randomized, cross over study on pharmacokinetics of single oral dose of 15mg and 45 mg Primaquine in healthy human volunteers - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/06/001803

Enrollment

Registered

2011-06-13

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

None listed

Interventions

Intervention1: Tablet Primaquine: Tablet Primaquine 15 mg single oral doses Intervention2: Tablet Primaquine: Tablet Primaquine 45 mg single oral doses Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants judged healthy by medical history and physical examination 2. Normal hematological and biochemical parameters and urine parameters 3. Participants have not taken any drug 15 days prior to and during the study 4. No previous history of gastrointestinal, hepatic, renal, cardiovascular or psychiatric diseases or symptoms. 5. Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 25.0 kg/m2, extremes included 6. Negative HBsAg and HIV ELISA 7. Female of non-child bearing potential or of child bearing potential with negative urine pregnancy test 8. Willing to provide written informed consent 9. Willing to comply with protocol instructions and duration of follow up.

Exclusion criteria

Exclusion criteria: 1. G6PD deficiency 2. Peripheral smear positive for any malarial species 3. History of malaria in the past one month. 4. Known hypersensitivity to primaquine or related drugs (e.g., iodoquinol) 5. Persons receiving treatment with other drugs producing hemolysis.(appendix 2) 6. Pregnant (even if a pregnant woman is G6PD normal, the fetus may not be) or breast feeding women 7. Participation in any investigational new drug study within 4 weeks prior to dosing. 8. Donation or loss of 300 ml or more of blood within 8 weeks prior to study start 9. History of autoimmunae disease or clinically significant drug allergy 10. History of drug or alcohol abuse within the last 6 months

Design outcomes

Primary

Measure	Time frame
Cmax, tmax, plasma half life (t1/2) , AUC0-t and AUC0-Ã¢Ë?Å¾, AUC at steady state, elimination rate constant (Kel), clearance (Cl), volume of distribution (Vd)Timepoint: 0 hr (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28 hrs postdose	—

Secondary

Measure	Time frame
Safety (adverse events) & laboratory parametersTimepoint: Throughout study period and at 28 hours postdose	—

Countries

India

Contacts

Public ContactDr Nithya Gogtay

NIL

njgogtay@hotmail.com

Outcome results