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A clinical trial to evaluate and compare the blood levels of two aliskiren modified release formulations with aliskiren market tablet in healthy adult subjects

An open-label, randomized, single-dose, crossover study to evaluate the relative bioavailability of two 150 mg aliskiren MR (modified release) microparticle formulations (capsule) vs. marketed 150mg tablet in healthy adult volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/12/002235
Enrollment
42
Registered
2011-12-15
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: Aliskiren 150mg MR capsule: Prototypr-1, single dose Intervention2: Aliskiren 150mg MR capsule: Prototype-2, Single dose Control Intervention1: Aliskiren 150mg tablets: single dose

Sponsors

Novartis Healthcare Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Smokers 2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 3. Pregnant or nursing (lactating) women 4. Impaired hepatic or relnal function test results 5. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result

Design outcomes

Primary

MeasureTime frame
To determine the bioavailability of aliskiren 150 MR microparticulate prototype formulations against marketed formulation.Timepoint: 4 periods, with a washout of at least 14 days between 2 doses.—

Secondary

MeasureTime frame
1. to characterize the effect of high-fat-high-calorie meal on the PK of aliskiren 150mg MR formulations 2. SafetyTimepoint: BP measurements are done at Screening, each baseline, Day 1 of each treatment period (at predose, 1, 2, 4, 8, 24 h post-dose) completion. ECGs taken at Screening, each baseline, completion. Safety samples (hematology, biochemistry and urinalysis)will be [performed at Screening, each baseline, completion. Monitoring of AE throughout the study.—

Countries

India

Contacts

Public ContactSivakumar Vaidyanathan

Clinical Sciences and Innovation, NIBR

sivakumar.vaidyanathan@novartis.com04067673288

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026