Bioequivalence study
Conditions
Interventions
Primaquine 15 mg tablet of IPCA
PQ 15 mg of Sanofi
Sponsors
The University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 55 years old, inclusive. 2) Gender: Male and/or non-pregnant, non-lactating female. 3) BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5). 4) Able to communicate effectively with study personnel. 5) Willing to provide written informed consent to participate in the study. 6) Non-smokers and nontobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study). 7) All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication
Exclusion criteria
Exclusion criteria: 1) History of allergic responses to Primaquine or other related drugs, or any of its formulation ingredients. 2) Have known significant diseases or clinically significant abnormal findings during screening (medical history, physical examination, laboratory evaluations, ECG). 3) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system. 4) History or presence of bronchial asthma. 5) Use of any hormone replacement therapy within 3 months prior to the first dose of study medication. 6) A depot injection or implant of any drug within 3 months prior to the first dose of study medication. 7) Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see http://medicine.iupui.edu/clinpharm/ddis/main-table). 8) History or evidence of drug dependence or of alcoholism or of moderate alcohol use (> 14 units/week: 1 unit = 1 shot of spirits, ½ pint of beer, 1.5 = 125 mL of wine Alcohol units - NHS (www.nhs.uk). 9) History of difficulty with donating blood or difficulty in accessibility of veins. 10) A positive hepatitis screen (includes subtypes B & C). 11) A positive test result for HIV antibody and / or syphilis (RPR). 12) Volunteers who have received a known investigational drug within seven elimination half-lives of the administered drug prior to first dose of study medication or who have participated in a clinical drug study or bioequivalence study within 90 days prior to the first dose of study medication, whichever is greater. 13) Volunteers who have donated blood or loss of blood > 300 mL within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater. 14) History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption. 15) Intolerance to venepuncture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Cmax •AUCt •AUCi, and •Tmax, Kel, AUC_%Extrap_obs, tHalf | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability, assessed by the detection of clinical and laboratory adverse events | — |
Countries
Ethiopia
Contacts
Public ContactFikir Tadesse
Researcher
Outcome results
None listed