A clinical trial to study bioequivalence between 2 formulations of drug called Aliskiren in healthy subjects

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/002815

Enrollment

150

Registered

2010-11-15

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: new formulation Control Intervention1: Aliskiren: market formulation

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male and female subjects age 18 to 55 years Subjects must weigh at least 50 kg and BMI within 18 to 30 kg/m2 Able to communicate well with the investigator,

Exclusion criteria

Exclusion criteria: Smokers who report cigarette use of more than 5 cigarettes per day. Subjects who use any prescription drugs, herbal supplements, OTC drugs or diet suppliments A past medical history of clinically significant ECG abnormalities.

Design outcomes

Primary

Measure	Time frame
To determine bioequivalence between two different formulations of AliskirenTimepoint: Nil	—

Secondary

Measure	Time frame
To determine safety and tolerability of AliskirenTimepoint: Nil	—

Countries

India

Contacts

Public ContactRajesh Karan

Novartis Healthcare Pvt. Ltd.

rajesh.karan@novartis.com04067674601

Outcome results