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Study to determine bioavailablity of 300 mg aliskiren mini-tablets vs 300 mg aliskiren market tablet.

An open label, randomized, three period, single-dose, crossover study to determine the bioavailability of 300 mg aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition and to evaluate the effect of food on the pharmacokinetics of 300 mg aliskiren minitablets in healthy subjects

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000855-15-Outside-EU/EEA
Enrollment
69
Registered
2012-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

Hypertension MedDRA version: 14.1 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: Aliskiren Product Code: SPP100 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ALISKIREN CAS Number: 173334-57-1 Current Sponsor code: SPP100 Concentration unit: mg milligra

Sponsors

Novartis Pharma Services AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. - Light smokers (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. - Participation in any clinical investigation within four (4) weeks prior to initial dosing. - Donation or loss of 400 mL or more of blood within eight (8) weeks prior to initial dosing. - Hemoglobin levels below 12 gm/100mL. - Significant illness within two (2) weeks prior to initial dosing. For a full list of exclusion criteria please refer to the protocol.

Design outcomes

Primary

MeasureTime frame
Main Objective: - To determine the bioavailability of a single oral dose of 300 mg aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition in healthy subjects - To evaluate the effect of food on the pharmacokinetics of a single oral dose of 300 mg aliskiren mini-tablets in healthy subjects;Secondary Objective: To evaluate the safety and tolerability of a single oral dose of 300 mg aliskiren minitablets administered with or without meal and a single oral dose of 300 mg aliskiren market tablet without meal in healthy subjects, respectively;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable—

Secondary

MeasureTime frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not appicable—

Countries

India

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma Services AG

clinicaltrial.enquiries@novartis.com+41613241111

Outcome results

None listed

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