Clinical trial NCT01875939: Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers
Official title: Phase-I Randomized, Open Label, Crossover Food-Effect and Absolute Bioavailability Study of WCK 2349 and WCK 771 in Healthy Adult Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Effect of Food
Keywords: healthy volunteers
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2013-06-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose).

This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK 2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771, IV to WCK 2349, oral) in future clinical trials in patients.

Detailed description: All the subjects will be checked-in into the clinical study facility on Day -1, the day prior to dosing. The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study. There will be a washout period of three days between each period. The subjects will continue to remain in the clinical facility for the entire duration of the study (completion of three periods in the study), including wash out period. Prior to check out procedure, detailed clinical examination will be done to confirm that subject has no safety issues.

Eligibility criteria: Inclusion Criteria:

* If female, postmenopausal for at least 1 year,surgically sterile or birth control measures.
* Body Mass Index (BMI) between 18 and 32
* No significant diseases
* No recent history of smoking or alcohol

Exclusion Criteria:

* Known history of hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
* 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.
* No receipt of a prescription drug or non-prescription drug .

Primary outcomes:
measure: Evaluate pharmacokinetics of WCK 2349 (Fed/Fasting)and WCK 771 Fasting
timeFrame: Approximately 11 days
Secondary outcomes:
measure: safety of oral WCK 2349 and intravenous WCK 771 in healthy adult human subjects
timeFrame: Approximately 11 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase I unit, 7551 Metro Center Drive, Suite 200
state: Texas
Study officials:
affiliation: PPD Phase I unit
name: Sabiha A Mondal, MD
role: PRINCIPAL_INVESTIGATOR
References: