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Bioequivalence study of Vonoprazan 20 mg Tablets in healthy adult human subjects under fasting conditions

An Open label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral bioequivalence study of Vonoprazan 20 mg Tablets by Laboratorios Leti, S.A.V., with INZELM 20mg tablets (Vonoprazan) of Takeda Pharmaceutical Company Limited in healthy adult human subjects under fasting conditions. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075427
Enrollment
30
Registered
2024-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Vonoprazan 20 mg Tablets: Name of the drug: Vonoprazan 20 mg Tablets, Route of administration: Oral, Frequency: single oral dose, Study duration:08 days Control Intervention1: INZELM 2

Sponsors

Laboratorios Leti, S.A.V.,
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 18.5 – 30.0 kg/m2 (both inclusive). 5. Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician

Exclusion criteria

Exclusion criteria: 1. Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs. 2. History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 3. History of severe infection or major surgery in the past 6 months. 4. History of Minor surgery or fracture within the past 3 months. 5. 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

Design outcomes

Primary

MeasureTime frame
To evaluate Pharmacokinetics parameters: Cmax, AUC0-t and AUC0-8Timepoint: From Day 01 to Day 08—

Secondary

MeasureTime frame
To evaluate Pharmacokinetics parameters:Tmax, AUC_%Extrap_obs, ?z and t1/2Timepoint: From Day 01 to Day 08—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Private limited

harish@icbiocro.com09900111997

Outcome results

None listed

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