A study to evaluate safety of Sun Pharmas 1334H, moxifloxacin and placebo in healthy subjects.

Phase 1

• Registration Number: CTRI/2012/03/002497
• Lead Sponsor: Sun Pharma Advanced Research Company Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. Availability of volunteer for the entire study period and willingness to adhere to protocol requirements.

2. Healthy human subjects having weight at least 50Kg and the subject¡¯s body mass index (BMI) must be within 18.5 ¨C 25.0 (Kg/m2) (inclusive).

3. Who voluntarily have given their written informed consent form (ICF) duly signed by the volunteer (section 12.3) to participate in the study.

4. Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.

5. Subjects whose screening laboratory values are within normal limits or considered by the physician/Clinical Investigator to be of no clinical significance.

6. Subjects whose 2 D-Echocardiography at screening 2 are normal will be enrolled into the study.

7. Subjects whose ECG¡¯s at screen 2 are within normal limits on manual reading and QTc intervals ¡Ü 450msec on instrument reading.

Exclusion Criteria

1. Marked baseline prolongation of QT/QTc interval (repeated demonstration of a QTc interval 450 ms)

2. History of additional risk factors for TdP (e.g. heart failure, hypokalemia, family history of long QT syndrome)

3. Use of concomitant medications that prolong the QT/ QTc interval

4. History or presence of:

i. Significant history of hypersensitivity or idiosyncratic reactions to cetirizine like compounds or to Moxifloxacin or any related products

ii. Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.

iii. Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.

iv. Moderate to heavy smoking (10 cigarettes/day) or consumption of tobacco products.

v. History of difficulty in swallowing or coming for follow up

vi. Clinically significant illness within 4 weeks before the start of the study

vii. Female subject

6. Participation in another clinical trial within the preceding 90 days of study starts.

7. Subjects who have:

i. Systolic blood pressure less than 90 mm of Hg and more than 140 mm of Hg

ii.Diastolic blood pressure less than 60 mm of Hg and more than 90 mm of Hg. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician/investigator.

iii. Pulse rate below 60/min. and above 100/min.

Any waiver of these inclusion and exclusion criteria must be approved and documented by the qualified investigator and the sponsor on a case-by-case basis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate QTc interval using time-matched 12-lead ECGTimepoint: In each of the study period 12-lead ECGâ??s will be recorded at 2 minute intervals in quintuplicate (five times) at all time points on day 1: 0 (pre-dose), 1, 2, 4, 8, 12 and 24h (dosing time of 2nd day); day 2: 0 (pre-dose), 1, 2, 4, 8, 12, 24 (day 3), 36 (day 3) and 48 hrs (day 4) of post dose.

Secondary Outcome Measures

Name	Time	Method
ot applicableTimepoint: Not applicable