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

Effect of sulphadoxine-pyrimethamine co-administration on pharmacokinetics of alpha beta arteether, an anti-malarial agent, in healthy male volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/11/002155

Enrollment

Registered

2011-11-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: sulphadoxime 500 mg pyrimethamine 25 mg plus single dose of alpha beta arteether: Single oral dose of 3 tablet stat of sulphadoxime 500 mg pyrimethamine 25 mg per individual along with

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

India

Contacts

Public ContactDr Vivek V Bhosale

Central Drug research Institute, lucknow

drvivekbhosale@cdri.res.in09450902041

Outcome results