bioequivalence study of Posaconazole 100 mg gastro-resistant tablets of Signature Phytochemical Industries

Completed

• Conditions: Normal, healthy, adult, human subject

• Registration Number: CTRI/2022/06/043016
• Lead Sponsor: Signature Phytochemical Industries

Brief Summary

An Open label, balanced, randomized, truncated, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Posaconazole 100 mg gastro-resistant tablets of Signature Phytochemical Industries with Noxafil® 100 mg gastro-resistant tablets(Posaconazole 100 mg) of Merck sharp & Dohme (New Zealand) Limited in healthy adult human subjects under fasting conditions.

Primary objective:

To compare pharmacokinetics of Posaconazole 100 mg gastro-resistant tablets of Signature Phytochemical Industries with Noxafil® 100 mg gastro-resistant tablets(Posaconazole 100 mg) of Merck sharp & Dohme (New Zealand) Limited in healthy adult human subjects under fasting conditions.Secondaryobjective:

To monitor and assess safety and tolerability of the investigationalproducts in healthy adult human subjects under fasting condition.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-04-07
• Study Start: 2022-06-06
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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 – 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 blood–forming organs.
• 4 History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
• 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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Cmax, and AUC0-72	From day 1 and day 19

Secondary Outcome Measures

Name	Time	Method
Tmax, λz and t1/2	From day 1 and day 19

Trial Locations

Locations (1)

ICBio Clinical Research Pvt; 🇮🇳 Bangalore, KARNATAKA, India

ICBio Clinical Research Pvt

🇮🇳Bangalore, KARNATAKA, India

Dr Priya R

Principal investigator

9900111997

pi.mail@icbiocro.com