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bioequivalence study of FDC of Azelnidipine 8 mg and Telmisartan 40 mg tablet of Signature Phytochemical Industries

An Open label, balanced, randomized, two-treatment, twoperiod, two-sequence, single oral dose, crossover, bioequivalence study of FDC of Azelnidipine 8 mg + Telmisartan 40 mg tablet of Signature Phytochemical Industries with Uniaz T 40mg tablet (Azelnidipine 8 mg + Telmisartan 40 mg) of Synokem Pharmaceuticals Ltd., in healthy adult human subjects under fasting conditions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042428
Enrollment
28
Registered
2022-05-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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 Azelnidipine 8 mg and Telmisartan 40 mg tablet: dose: Azelnidipine 8 mg and Telmisartan 40 mg, frequency: Single dose one time during the study, route of administration: oral, d

Sponsors

Signature Phytochemical Industries
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study. 2.Willing to be available for the entire study period and to comply with protocol requirements. 3.Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age. 4.Body mass index in the range of 18 â?? 30 kg/m2 (both inclusive). 5.Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12 to 16 g/dL for female.

Exclusion criteria

Exclusion criteria: 1.Found positive (+ve) on rapid test for COVID-19 during screening. 2.Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women. 3.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and bloodâ??forming organs. 4.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.

Design outcomes

Primary

MeasureTime frame
Cmax, AUC0-t and AUC0-â??Timepoint: From day 1 and day 19—

Secondary

MeasureTime frame
Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: From day 1 and day 19—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com9900111997

Outcome results

None listed

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