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A clinical trial to study the effect of light meal on Fixed Dose Combination of Aliskiren (300mg)/ Amlodipine (5mg)and Hyderochlorothiazide 25mg) in Healthy human subjects

An open label, randomized, 2 x 3 crossover study to evaluate bioequivalence between fixed-dose combination of SAH100 tablets (300/5/25mg aliskiren/amlodipine/HCTZ) and free combination of market formulation of 300mg aliskiren tablet, and clinical service formulations of 5mg amlodipine and 25mg hydrochlorothiazide in healthy subjects under light meal conditions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/001323
Enrollment
124
Registered
2010-10-21
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: FDC Of Aliskiren/Amlodipine/HCTZ: 300/5/25 Mg - Single Dose Control Intervention1: Free Combination Of Aliskiren+Amlodipine+HCTZ: 300 Mg + 5 Mg 25 Mg - Single Dose

Sponsors

Novartis Healthcare Pvt. Ltd. Raheja IT Park, Mind Space - Bld # 6, Hitech City,Village - Madhapur, Hyderabad 500081, India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Healthy male and female subjects, aged 18 to 55 years (inclusive) and in good health as determined by past medical history, physical examination, vital signs assessments, electrocardiogram, and laboratory tests at screening. - Non-smokers. -Body mass index (BMI) must be 18 ? 30 kg/m2 (inclusive) and subjects must weigh at least 50 kg.

Exclusion criteria

Exclusion criteria: -Female subjects of child bearing potential. -Lactating and breast feeding females. -Hemoglobin levels below 12.0 g/dl. -A past and current medical history of clinically significant ECG abnormalities. -A known hypersensitivity or other intolerance to the study drugs or drugs similar to the study drug. -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. -A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. -History of head and neck angioedema. -History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening.

Design outcomes

Primary

MeasureTime frame
To determine whether fixed-dose combination of 300/5/25 mg aliskiren/ amlodipine/ HCTZ tablet is bioequivalent to the free combination of the market formulation of 300 mg aliskiren tablet, and clinical service formulations of 5 mg amlodipine capsule and 25 mg hydrochlorothiazide (HCTZ) capsule in healthy subjects when administered in light meal conditionsTimepoint: nil—

Secondary

MeasureTime frame
To assess the safety and tolerability of a single oral dose of the fixed combination and the free combination of aliskiren/ amlodipine/ hydrochlorothiazide 300/5/25 mg in healthy subjectsTimepoint: nil—

Countries

India

Contacts

Public ContactRajesh Karan

Novartis Healthcare, Pvt. Ltd.,

rajesh.karan@novartis.com040 67674601

Outcome results

None listed

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