Chloroquine/proguanil is used for malaria chemoprophylaxis in areas where chloroquine-resistant Plasmodium falciparum malaria is prevalent, except in regions of Africa where chloroquine/proguanil is no longer effective. Ciprofloxacin is a fluoroquinolone antibiotic used to treat a wide variety of infections, such as traveller`s diarrhoea. Only healthy subjects will be treated in this study.
Conditions
Interventions
Trade Name: Avloclor tablet 250mg
Product Name: chloroquine
Product Code: not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: chloroquine phosphate
CAS Number: 50-63-5
Other descriptive na
Sponsors
Dstl
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: To participate in this study, subjects must meet the following criteria: 1. Ability and willingness to give written informed consent prior to study participation 2. Healthy male subjects aged between 18 and 50 years (inclusive) 3. Body Mass Index (BMI) within the range of > 21 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from participation in the study: 1. Presence of any clinically significant medical condition as determined by the Medical Advisor 2. Any clinically significant haematological or biochemical abnormality as determined by the Medical Advisor 3. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug (e.g. renal or liver disease, respiratory, immunological, endocrine or neurological disorders) 4. Any ECG abnormality other than sinus bradycardia or respiratory sinus arrhythmia 5. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the investigational medicinal products 6. Positive test for hepatitis B surface antigen 7. History or evidence of alcohol abuse defined as an intake of more than 28 units per week (4 units per day), where 1 unit corresponds to 250 ml beer, 20 ml spirits/liqueur or one glass (100 ml) of wine 8. Participation in another clinical study within the three months prior to screening 9. Use of any prescription medication within the 14 days prior to screening 10. Use of any non-prescription medication within the last 7 days (apart from paracetamol), which may, in the opinion of the Medical Advisor, impact the safety aspects and/or objectives of the study 11. Donation of blood or blood products within the 3 months prior to screening, or the intention to donate blood or blood products within 3 months after completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether any interaction occurs with the concomitant oral administration of chloroquine/proguanil and ciprofloxacin by measuring pharmacokinetic (PK) parameters. These parameters will be assessed by: - determination of the PK profiles following dosing with: chloroquine and proguanil together, chloroquine and proguanil together in combination with ciprofloxacin, ciprofloxacin alone. - determination of the urinary clearance kinetics following dosing with: chloroquine and proguanil together, chloroquine and proguanil together in combination with ciprofloxacin, ciprofloxacin alone.;Secondary Objective: To assess the safety and tolerability of concomitant oral administration of chloroquine/proguanil with ciprofloxacin.;Primary end point(s): Statistical comparisons will be made by analysis of variance with appropriate post-hoc testing: • Between group comparisons of the pharmacokinetic parameters for chloroquine and proguanil at day 22 • Between group comparisons of the chloroquine and proguanil clearance parameters at days 22, 23 and 24. • Within group comparisons (group 1) of the ciprofloxacin pharmacokinetic parameters at days 1 and 22 • Within group comparisons (group 1) of the ciprofloxacin clearance parameters at days 1 and 22. | — |
Countries
United Kingdom
Outcome results
None listed