Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349
NCT ID: NCT04874324
Last Updated: 2022-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2011-03-17
2011-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
QUADRUPLE
Study Groups
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WCK 2349
WCK 2349 800mg, 1000mg, and 1200mg . 1 dose given orally twice daily at 12 hourly interval for five days.
Dosage form : Oral
WCK 2349 Oral
1 dose given orally twice daily at 12 hourly interval for five days.
Placebo
Matching Placebo administered as Oral
Placebo Oral
Subjects will receive matching placebo
Interventions
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WCK 2349 Oral
1 dose given orally twice daily at 12 hourly interval for five days.
Placebo Oral
Subjects will receive matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Wockhardt
INDUSTRY
Responsible Party
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Principal Investigators
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Ashima Bhatia, MD
Role: STUDY_DIRECTOR
Wockhardt Ltd
Other Identifiers
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WCK 2349/ P-I/ MD/ 08
Identifier Type: -
Identifier Source: org_study_id
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