Efficacy and safety of SPILs 1301 tablets, 200 mg in subjects with travelers diarrhea : A Randomized, Double blind, Parallel group, Active and Placebo Controlled, Clinical Endpoint Bio equivalence Study
Not Applicable
- Conditions
- Health Condition 1: null- acute travelersâ?? diarrheaHealth Condition 2: R197- Diarrhea, unspecified
- Registration Number
- CTRI/2017/03/007996
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 1
Inclusion Criteria
1.Willing to participate and give written informed consent.
2.Able and willing to comply with the protocol, including availability for all scheduled clinic visits.
3.woman of child bearing potential - having a negative urine pregnancy test prior to beginning the therapy and ready to use effective contraceptive methods during the study.
4.Experiencing at least three unformed stools recorded within the 24 hours
Exclusion Criteria
1.Pregnant, breast feeding or planning a pregnancy.
2.Having active, uncontrolled, or clinically significant diseases
3.Use of any drug such as aspirin or ibuprofen, which can cause GI bleeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EfficacyTimepoint: Day 5 (end of study visit)
- Secondary Outcome Measures
Name Time Method oneTimepoint: None