A clinical trial to study the effects of coadministration of two antimalarial drugs, alpha beta arteether and sulphadoxine-pyrimethamine in healthy volunteers.

Phase 4

Active, not recruiting

Registration Number: CTRI/2011/11/002155

Lead Sponsor: Central Drug research Institute lucknow

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Willing to give written, informed consent prior to inclusion in the study

2. Willing to comply with protocol requirements, ability to comprehend the full nature and purpose of the study, including possible risks and side effects; and to comply with the requirements of the entire study

3. Normal physical & systemic examination

4. No abnormality detected on X-ray chest & ECG

5. No laboratory evidence of hepatic, renal or cardiac dysfunction

Exclusion Criteria

1.Are on any form of medication, smokers or who have consumed tobacco, alcohol, grapefruit juice during a period of 7 days before the study.

2. History of any drug taken in past 15 days.

3. Have been treated with any known enzyme inducing or inhibiting drugs within 30 days of the study.

4.Suffering from any chronic disease which is likely to interfere with the metabolism/evaluation of test drugs.

5. History of participation in any clinical trial in last three months

6.Patients on treatment with corticosteroids, anti-convulsants, bronchodilators, etc.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of coadministration of two drugs will be studied by measuring pharmacokinetic parameters of both drugs. The parameters will be <br/ ><br>Primary Parameter <br/ ><br>Peak plasma concentrations(Cmax) <br/ ><br>Area under plasma concentration-time curve up to t hr (AUC 0-t) <br/ ><br>Area under plasma concentration-time curve up to infinity (AUC 0-â??)Timepoint: ohr,30min, 1hr,2hr,4hr,8hr,12hr, 24hr,48hr,72hr, 7th day, 14th day, 21 day

Secondary Outcome Measures

Name	Time	Method
Time to reach peak plasma concentrations (Tmax) <br/ ><br>Elimination rate constant (Kel) <br/ ><br>Elimination half-life (t1/2) <br/ ><br>Clearance (Cl) <br/ ><br>Volume of Distribution (Vd)Timepoint: ohr,30min, 1hr,2hr,4hr,8hr,12hr, 24hr,48hr,72hr, 7th day, 14th day, 21 day