A clinical trial to evaluate and compare the blood levels of aliskiren mini-tablets with aliskiren market tablet under fasted condition and futher evaluate aliskiren mini-tablets under fed condition in healthy subjects

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

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000723

Enrollment

Registered

2009-09-23

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 mini tablets: 300 mg (1 Mini-Tablet = 3.125mg, 96 x 3.125= 300 mg) 96 mini-tablets will be administred as a single dose which is equivalent to 300 mg Control Intervention1: N

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male and female subjects ( women of non-child bearing potential)

Exclusion criteria

Exclusion criteria: Female subjects of child bearing potential. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.

Design outcomes

Primary

Measure	Time frame
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 subjectsTimepoint: Single Dose Of SPP100 Administration Under Fasting Or Fed Condition Followed By PK Sample Collection Till Day 8 (Except On Day 6)	—

Measure

Time frame

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 subjectsTimepoint: Single Dose Of SPP100 Administration Under Fasting Or Fed Condition Followed By PK Sample Collection Till Day 8 (Except On Day 6)

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Secondary

Measure	Time frame
To evaluate the safety and tolerability of a single oral dose of 300 mg aliskiren mini-tablets administered with or without meal and a single oral dose of 300 mg aliskiren market tablet in healthy subjects without meal, respectively.Timepoint: Number Of AEs From First Dosing To End Of Study Evaluation And Number Of SAEs From Date Of ICF To 4weeks After Last Dose Administration. Safety assessments will also include vital signs, blood pressure and pulse rate) standard clinical laboratory evaluations. Blood pressure, pulse rate: screening, each baseline, pre- dose* and 2, 4, 12 and 24* hours post dose, end of study* Note: measurements are supine, or supine and after 3 min standing if indicated by an *asterisk) Hematology; Blood chemistry; Urinalysis: screening, each baseline, end of study	—

Measure

Time frame

To evaluate the safety and tolerability of a single oral dose of 300 mg aliskiren mini-tablets administered with or without meal and a single oral dose of 300 mg aliskiren market tablet in healthy subjects without meal, respectively.Timepoint: Number Of AEs From First Dosing To End Of Study Evaluation And Number Of SAEs From Date Of ICF To 4weeks After Last Dose Administration. Safety assessments will also include vital signs, blood pressure and pulse rate) standard clinical laboratory evaluations. Blood pressure, pulse rate: screening*, each baseline*, pre- dose* and 2, 4, 12 and 24* hours post dose, end of study* Note: measurements are supine, or supine and after 3 min standing if indicated by an *asterisk) Hematology; Blood chemistry; Urinalysis: screening, each baseline, end of study

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Countries

India

Contacts

Public ContactSiva Kumar Vaidyanathan

Novartis Healthcare Pvt. Ltd.

rajesh.karan@novartis.com+91 40 67672945, +919160089988

Outcome results