Evaluation of capsules solubility (two groups)
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000026036
- Lead Sponsor
- TTC Co.,Ltd.
- Brief Summary
Conventional film capsules collapsed in about 20 to 40 minutes after reaching the stomach. The new film capsules did not dissolve in the stomach and collapsed in about 40 to 80 minutes after reaching the small intestine. From the above results, it was demonstrated that the new film capsule functions as an enteric capsule even in the human body. In addition, adverse events did not occur after ingestion for conventional film capsules and new film capsules, and safety problems were not observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 12
Not provided
(1) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease (2) Subjects having possibilities for emerging allergy related to the study (3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (5) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (6) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (7) Subjects judged as unsuitable for the study by the investigator for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disintegration and disintegration time of capsule in X-ray contrast
- Secondary Outcome Measures
Name Time Method