CTRI/2022/07/044366Completed未知
An open label, multiple dose, single period, pharmacodynamic endpoint clinical study of Sugar FreeSenna Medicated Chew/Gummy 4.3 mg of Sennosides in terms of Laxative effect in subjects withoccasional constipation - NA
Medicated Chews LLC0 sites12 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
Inclusion Criteria
- •1)Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study;
- •2)Willing to be available for the entire study period and to comply protocol requirements;
- •3)Body mass index in the range of 18.50 ââ?¬â?? 29.99 kg/m2 (both inclusive);
- •4)With a current diagnosis of untreated constipation for ââ?°Â¤ 7 days based on
- •5)signs/symptoms of straining and hard or lumpy stools or inability to have a bowel
- •6)movement (BM) within 48 hour prior to randomization.
- •7)Normal health status as determined by baseline medical and medication history, at
- •8)the time of screening and vital signs measurements and physical examination at the time of screening as well as check-in;
- •9)Normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis;
- •10)Normal or clinically non-significant 12-lead ECG recording;
- •11)Non-smokers or mild/moderate smokers with not more than 10 bidis/cigarettes/pipes per day, and willing to abstain from smoking or chewing any tobacco containing products at least 72.00 hours prior to check-in until study completion
- •12)Willing to abstain from alcohol or alcoholic products at least 24.00 hours prior to check-in until study completion;
- •13)Willing to abstain from xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to check-in until study completion;
- •14)Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in until study completion;
- •15) For female subjects:
- •a)Negative urine pregnancy test during screening and negative serum Ã?²-hCG test at the time of check-in;
- •b)Female subjects with child bearing potential or those within their first two years of onset of menopausal syndrome willing to either abstain from sexual intercourse, or should use acceptable birth control methods for at least 15 days before check-in till 15 days post last-dose / entire study period. [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed)].
Exclusion Criteria
- •1)Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs;
- •2)Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;
- •3)Subjects on other medications for the treatment of constipation;
- •4)Subjects with irritable bowel syndrome (IBS) or any other digestive disorders;
- •5)Any major illness or hospitalized within 90 days prior to check-in;
- •6)Requiring medication for any ailment having enzyme-modifying activity within one month prior to check-in and throughout the study;
- •7)Use of any depot injection or an implant of any drug within 3 months prior to check in and throughout the study;
- •8) Use of any prescribed medication (including herbal medicines and vitamin supplements) or OTC products within 30 days prior to check-in and throughout the study;
- •9)History or presence of significant gastric and/or duodenal ulceration;
- •10)Difficulty in swallowing tablets or capsules;
- •11)Use of any recreational drug or history of drug addiction;
- •12) Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 90 days prior to check-in;
- •13) Positive urine alcohol and urine drug of abuse tests during check-in;
- •14)Reactive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies;
- •15) Lactating or nursing female subjects;
- •16) Female subjects using hormonal contraceptive (either oral/implants)
Investigators
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