Health Condition 1: null- acute travelersâ?? diarrhea Health Condition 2: R197- Diarrhea, unspecified
Conditions
Interventions
Intervention1: SPIL1301: 200 mg tablet will be self-administered 3 times a day for three days
(i.e. Day 1, Day 2 and Day 3).
Control Intervention1: Reference1301: 200 mg tablet will be self-administer
Sponsors
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EfficacyTimepoint: Day 5 (end of study visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Ltd.
Outcome results
None listed