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A clinical trial to evaluate the bioequivalenc of new formulation of aliskiren (SPP100) 300 mg tablet administered after light meal.

An open-label,randomized, single-dose, two-treatment, two-sequence,three-period, replicate crossover study to determine the bioequivalence of SPP100 (aliskiren) 300mg tablets (small tablet vs.marketed formulation) in healthy adult subjects under light meal conditions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/04/002573
Enrollment
136
Registered
2012-04-13
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 300 mg small tablet (test drug): Single dose Control Intervention1: Aliskiren 300 mg marketed tablet (reference drug): Single dose

Sponsors

Novartis Healthcare Private Limited
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 50 kg & 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 renal function test results. 5.A positive Hepatatis B surface antigen (HBsAg)or Hepatatis C test result.

Design outcomes

Primary

MeasureTime frame
To determine the bioequivalence of aliskiren 300 mg tablets (small tablet vs. marketed formulation) in healthy subjects when administered under light meal conditionsTimepoint: 3 periods, with a washout of at least 14 days between two treatments.—

Secondary

MeasureTime frame
SafetyTimepoint: BP measurements are done at Screening, each baseline, Day 1 of each treatment period (at predose, 1, 2, 4, 8, 24 & 72 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