An Open label, balanced, randomized, two-period, two-treatment, two-sequence, single oral dose, crossover Bioequivalence study of RIFAIZO PE in healthy adult human subjects under fasting conditions

Not Applicable

Completed

• Registration Number: CTRI/2022/03/041028
• Lead Sponsor: Swiss Parenterals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-08-20
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 31

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 13.8 to 17.2 grams per deciliter (g/dL) for men and 12.1 to 15.1 g/dL for female.

6.Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period.

7.With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no. 9.1).

8.With a normal or clinically non-significant 12-lead ECG.

9.With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.

Exclusion Criteria

1.Haemoglobin level less than 13.5 grams per deciliter for men and 12 grams per deciliter for women.

2.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and bloodâ??forming organs.

3.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.

4.Taking any iron preparation already at the time of enrolment.

5.History of severe infection or major surgery in the past 6 months.

6.History of Minor surgery or fracture within the past 3 months.

7.Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction.

8.Any major illness or hospitalized within 90 days prior to the first dosing.

Study & Design

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