Safety, Tolerability and Pharmacokinetics of CDD-2101 in Health Volunteers
- Conditions
- Constipation - Functional
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - An individual must meet all the criteria below to be eligible for participation in<br> this study:<br><br> 1. Male or female<br><br> 2. Aged 18-65 years (inclusive)<br><br> 3. Body weight of 50kg or more<br><br> 4. BMI 18.5-29.9 kg/m2 (inclusive)<br><br> 5. Normal hepatic: aspartate aminotransferase (AST), alanine aminotransferase<br> (ALT), and gamma glutamyl transferase (GGT) and total bilirubin not elevated<br> more than 1.2-fold above the upper limit of normal (ULN)<br><br> 6. Normal renal function: glomerular filtration rate (GFR) = 90 mL/min/1.7m2<br><br> 7. Understand the study procedures and agree to participate by providing written<br> informed consent<br><br> 8. Be willing and able to comply with all study procedures and restrictions<br><br> 9. Be a nonsmoker who has not used tobacco- or nicotine-containing products (e.g.,<br> nicotine patch) for at least 6 months before administration of the<br> investigational drug<br><br> 10. Be judged to be in good health by the investigator, based on clinical<br> evaluations including laboratory safety tests, medical history, physical<br> examination, 12-lead ECG, and vital sign assessment performed at the Screening<br> Visit and before administration of the investigational drug<br><br> 11. Contraceptive use by men or women should be consistent with local regulations<br> regarding the methods of conception for those participating in clinical study<br><br>Exclusion Criteria:<br><br> - An individual who meets any of the following criteria will be excluded:<br><br> 1. Pregnant, trying to become pregnant or lactating<br><br> 2. Use of any prescription, non-prescription drug and investigational drug within<br> 30 days prior to administration of the study drug<br><br> 3. Has a substance abuse disorder<br><br> 4. Has a history of clinically significant endocrine, gastrointestinal (including<br> motility disorder and intestinal obstruction), cardiovascular, hematological,<br> hepatic, immunological, renal, respiratory, genitourinary, or major<br> neurological (including stroke and chronic seizures) abnormalities or diseases<br><br> 5. Has a history of cancer (malignancy)<br><br> 6. Has a known hypersensitivity to any component of the formulation of CDD-2101,<br> its related compounds or placebo, or allergy to Chinese herbal medicine<br><br> 7. Has a history of significant multiple and/or severe allergies (e.g., food, drug<br> or latex allergy) or has had an anaphylactic reaction or significant<br> intolerability to prescription or nonprescription drugs or food<br><br> 8. Had major surgery, donated, or lost 1 unit of blood (approximately 500 mL)<br> within 8 weeks before administration of the investigational drug<br><br> 9. Diagnosis of bowel disorders based on the Rome IV criteria<br><br> 10. Has a history of positive for hepatitis B, hepatitis C or HIV<br><br> 11. Has a history of alcohol consumption exceeding 2 standard drinks per day on<br> average (1 standard drink is approximately equivalent to: beer (354 mL/12<br> ounces), wine (118 mL/4 ounces), or distilled spirits (29.5 mL/1 ounce)<br><br> 12. Has participated in another investigational trial within 4 weeks before the<br> pretrial (Screening) visit. The 4-week window will be derived from the date of<br> the last trial procedure and/or AE related to the trial procedure in the<br> previous trial to the pretrial/Screening Visit of the current trial.<br><br> 13. Is an employee or immediate family member (e.g., spouse, parent, child,<br> sibling) of the sponsor or Contract Research Organization (CRO)<br><br> 14. Having received another investigational drug or been participated in an<br> investigational drug or device study within 30 days before administration of<br> the investigational drug.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method potential AEs
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration [Cmax] - cannabisin B;Maximum plasma concentration [Cmax] - rhein;Maximum plasma concentration [Cmax] - magnolol;Maximum plasma concentration [Cmax] - paeoniflorin;Maximum plasma concentration [Cmax] - albiflorin;Maximum plasma concentration [Cmax] - synephrine;Maximum urine concentration [Cmax] - cannabisin B;Maximum urine concentration [Cmax] - rhein;Maximum urine concentration [Cmax] - aloe emodin;Maximum urine concentration [Cmax] - amygdalin;Maximum urine concentration [Cmax] - magnolol;Maximum urine concentration [Cmax] - honokiol;Maximum urine concentration [Cmax] - paeoniflorin;Maximum urine concentration [Cmax] - albiflorin;Maximum urine concentration [Cmax] - synephrine