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

Pharmacokinetics Clinical Trial

Official title:

Phase-I Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349 Under Fasting Conditions in Adult Healthy Human Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04874324
• Other study ID #: WCK 2349/ P-I/ MD/ 08
• Status: Completed
• Phase: Phase 1
• Start date: March 17, 2011
• Est. completion date: June 25, 2011

Study information

• Verified date: November 2022
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 25, 2011
• Est. primary completion date: May 4, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• WCK 2349 Oral
1 dose given orally twice daily at 12 hourly interval for five days.

Other:
• Placebo Oral
Subjects will receive matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wockhardt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety & tolerability of multiple doses of WCK 2349	By monitoring the adverse events reported	12 days
Primary	To evaluate the pharmacokinetics of multiple doses of WCK 2349	Measuring Cmax Maximum observed plasma concentration.	5 days