Examining whether any interactions occur between the antibiotic Ciprofloxacin and the antimalarial treatment Chloroquine/Proguanil

Phase 4

Completed

• Conditions: Pharmacokinetics; Not Applicable

• Registration Number: ISRCTN20647977
• Lead Sponsor: Defence Science and Technology Laboratory (Dstl)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-06-14
• Study Start: 2019-04-05
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 16

Inclusion 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 30 kg/m2
4. Vital signs within the following ranges:
4.1. Pulse rate 40-90 bpm
4.2. Systolic blood pressure 90-140 mmHg
4.3. Diastolic blood pressure 50-90 mmHg
5. Ability to communicate well with the Investigator and to comply with the requirements of the study.

Exclusion Criteria

1. Presence of any clinically significant medical condition as determined by the Investigator or Medical Advisor
2. Any clinically significant haematological or biochemical abnormality as determined by the Investigator or 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 or Hepatitis C antibody
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 Investigator or 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Any interaction occurring with concomitant oral administration of chloroquine/proguanil with ciprofloxacin was measured using pharmacokinetic (PK) parameters at day 1, day 2, day 22, and days 23to 25. These parameters were assessed during administration of:<br> 1.1. Chloroquine and Proguanil together<br> 1.2. Chloroquine and Proguanil together in combination with Ciprofloxacin<br> 1.3. Ciprofloxacin alone<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Safety of concomitant oral administration of Chloroquine/Proguanil with Ciprofloxacin was measured using the following measures pre and post-study:<br> 1.1. Medical History and Physical Examinations<br> 1.2. Vital Signs (supine blood pressure and pulse rate)<br> 1.3. Laboratory Safety Screening: haematology, biochemistry and urinalysis were carried out pre and post study.<br> 2. Tolerability of concomitant oral administration of Chloroquine/Proguanil with Ciprofloxacin was measured using Adverse Event Recording: performed throughout the study.<br>