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

Not Applicable

Completed

• Registration Number: CTRI/2022/05/042428
• Lead Sponsor: Signature Phytochemical Industries

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-05-29
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

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

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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax, AUC0-t and AUC0-â??Timepoint: From day 1 and day 19

Secondary Outcome Measures

Name	Time	Method
Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: From day 1 and day 19