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Trial record 10 of 914 for:    tablet | Japan

Bioequivalence Study of NPC-12 (Sirolimus) Granules and Tablets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03765944
Recruitment Status : Completed
First Posted : December 5, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Nobelpharma

Brief Summary:
The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults

Condition or disease Intervention/treatment Phase
Bioequivalence Study Drug: sirolimus Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single Dose, Randomized, Open-label, 2-Period, 2-way Crossover, Bioequivalence Study of Sirolimus Granules and Sirolimus Tablets in Japanese Healthy Adults
Actual Study Start Date : December 5, 2018
Actual Primary Completion Date : December 29, 2018
Actual Study Completion Date : December 29, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Active Comparator: NPC-12 granule
NPC-12 granules (1.0g: 2mg sirolimus)
Drug: sirolimus
SIngle administration under fasted condition

Active Comparator: NPC-12T tablet
NPC-12T 2 tablets (2mg sirolimus)
Drug: sirolimus
SIngle administration under fasted condition




Primary Outcome Measures :
  1. Blood sirolimus concentration [ Time Frame: Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours) ]
    Whole blood concentration of sirolimus will be measured and compared between NPC-12 granules and NPC-12T tablets.



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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Japanese healthy subjects aged 20 to 39 years of age
  2. Subjects with BMI ≥ 18.5 kg/m2 and < 25.0 kg/m2
  3. Subjects who are considered by the investigator as suitable for participation in the trial from lab test results at screening
  4. Subjects who are considered by the investigator as suitable for participation in the trial from lab test results on the day before administration
  5. Subjects who write informed consent
  6. Subjects who are able to comply with the study requirements during the study period

Exclusion Criteria:

  1. Subjects who have a history of hypersensitivity to sirolimus or sirolimus derivative
  2. Subjects who have a history of hypersensitivity or allergies to other drug
  3. SUbjects who have an acute or chronic infectious diseases
  4. Subjects who have a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments
  5. Subjects who have diagnosed with alcoholism or a history of alcoholism
  6. Subjects who have an abnormal findings (pneumonia, etc) from the result of chest CT at screening
  7. Subjects who have been administered other investigational drug within 12 weeks before the initial administration
  8. Subjects who have performed blood collection or donation as follows

    • Collected or donated 200 ml or more whole blood within 4 weeks before the initial administration
    • Male subject; collected or donated more than 400 mL whole blood within 12 weeks before the initial administration
    • Female subjects; collected or donated more than 400 mL whole blood within 16 weeks before the initial administration
    • Collected or donated blood component within 2 weeks before the initial administration
  9. Subjects who have positive results for HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen/antibody, or syphilis
  10. Subjects who received any non-prescription or prescription drug within 12 weeks before the initial administration
  11. Subjects who are pregnant/lactating, or do not agree to contraception during the period from the screening until 8 weeks after the final administration due to planning to become pregnant
  12. Subjects who cannot speak, read and write in Japanese
  13. Subjects who are considered by the investigator as unsuitable for participation in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765944


Locations
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Japan
Clinique Soigner
Matsudo, Chiba, Japan, 270 -2231
Sponsors and Collaborators
Nobelpharma

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Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT03765944     History of Changes
Other Study ID Numbers: NPC-12T-1
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs