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

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043016
Enrollment
24
Registered
2022-06-03
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: Posaconazole 100 mg gastro-resistant tablet: dose: 100 mg, frequency: Single dose one time during the study, route of administration: oral, duration: period I, period II. Control Interv

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. 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

Design outcomes

Primary

MeasureTime frame
Cmax, and AUC0-72Timepoint: From day 1 and day 19—

Secondary

MeasureTime frame
Tmax, 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