Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349

Wockhardt

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics

Treatments

Other: Placebo Oral

Drug: WCK 2349 Oral

Study type

Interventional

Funder types

Industry

Identifiers

NCT04874324

WCK 2349/ P-I/ MD/ 08

Details and patient eligibility

About

The present study is planned to assess the safety, tolerability and pharmacokinetic profile of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare the safety, tolerability and pharmacokinetic data with the data observed in similar studies conducted in India.

Enrollment

36 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Must be healthy males or non-pregnant females
Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg / height in m2
Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordings.
Should test negative for drugs of abuse and urine alcohol test.

Exclusion criteria

Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
Any history or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.