FindTrial
Sign In

Bioequialence study of two novel strengths of Coartem

A randomized, open-label, single dose, two-period, within formulation crossover study of Coartem to evaluate the bioequivalence between a novel single 4-in-1 tablet and a dose of four individual tablets and between a novel single 3-in-1 tablet and a dose of three individual tablets in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/12/002256
Enrollment
120
Registered
2011-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Coartem® (each tablet 20mg artemether/120mg lumefantrine) tablet: The medication is administered as a single dose under fed condition Intervention2: 60mg artemether/360mg lumefantrine)

Sponsors

Novartis Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy subjects 2. Female subjects must be of non-child bearing potential 3. Subjects must weigh at least 50kg & their BMI 18 to 30kg/m2 for participation

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 2. Smokers 3. Laboratory screening tests within normal ranges. 4. Pregnant or nursing (lactating) women,

Design outcomes

Primary

MeasureTime frame
To compare the drug exposure between each respective new formulation to the approved reference formulationTimepoint: â?¢ At the following time points, 3 mL of blood should be drawn (about 1.5 mL plasma will be generated) for the analysis of artemether and dihydroartemisinin: predose (i.e. 0 h), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post dose. â?¢ At the following time points, 2 mL of blood should be drawn (about 0.7 mL plasma will be generated) for the analysis of lumefantrine: predose (i.e. 0 h), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 120, 168, 216 and 264 hours post dose.—

Secondary

MeasureTime frame
SafetyTimepoint: BP measurement: Screening, each baseline, each treatment period Day 1 at pre-dose, 1, 2, 4, 8, Day 2 at 24, Day 3 at 48 h post-dose and at completion. ECG evaluation: Screening, each baseline, Day 1 of each treatment period (at pre-dose, 2 h post-dose) and completion. Safety samples (hematology, Blood chemistry & Urinalysis): Screening, each baseline, Day 3 of each treatment period at 48 h post-dose, 264 h post dose in period 1 and completion. Monitoring of AE throughout the study.—

Countries

India

Contacts

Public ContactSivakumar Vaidyanathan

Novartis Healthcare Pvt., Ltd.,

sivakumar.vaidyanathan@novartis.com914067674616

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 10, 2026