UMIN-CTR Clinical Trial

Public title

Clinical study about in vitro - in vivo correlation in supersaturation of poorly soluble basic drug

Acronym

Clinical study about IVIVC in poorly soluble basic drug

Scientific Title

Clinical study about in vitro - in vivo correlation in supersaturation of poorly soluble basic drug

Scientific Title:Acronym

Clinical study about IVIVC in poorly soluble basic drug

Region

Japan

Condition

Healthy male

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Albendazole tablet, acetaminophen syrup, diluted hydrochloric acid and methacrylic acid copolymer LD are administered by 3 group 3 period crossover for fasting single oral cassette dose. We compare with their plasma concentrations.

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Pharmacokinetics of albendazole and albendazole sulfoxide

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Single oral administration of albendazole and acetaminophen

Interventions/Control_2

Single oral administration of albendazole, acetaminophen and diluted hydrochloric acid

Interventions/Control_3

Single oral administration of albendazole, acetaminophen, diluted hydrochloric acid and methacrylic acid copolymer LD

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

40

years-old

>

Gender

Male

Key inclusion criteria

1. Healthy Japanese male subjects who provide signed written informed consent.
2. Subjects between 20 and 40 (inclusive) year of age at the time of consent.
3. Subjects with BMI <=18.5 and >25.0 at the time of screening.
4. Subjects judged as adequate for this study by study physician.

Key exclusion criteria

1. Subjects who had gastrointestinal resection and vagotomy
2. Subjects with present illness which requires treatment.
3. Subjects with past medical history which was considered not adequate for this study.
4. Subjects with past history of drug allergy.
5. Subjects who took prescribed medicine and/or OTC drug 1 week prior to admission of period 1.
6. Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200 mL within 4 weeks, and/or blood component within 2 weeks prior to admission of period 1.
7. Subjects who participated in a clinical trial and was administered study drug within 16 weeks prior to admission of period 1.
8. Subjects with history of alcohol and/or drug abuse.
9. Subjects who were judged not appropriate for this study by study physician.

Target sample size

18

Name of lead principal investigator

1st name
Middle name
Last name	Takuya Fujita

Organization

Ritsumeikan University

Division name

College of Pharmaceutical Sciences

Zip code

Address

1-1-1 Noji-higashi, Kusatsu, Shiga 525-8577 JAPAN

TEL

077-561-5974

Email

fujita-t@ph.ritsumei.ac.jp

Name of contact person

1st name
Middle name
Last name	Takuya Fujita

Organization

Ritsumeikan University

Division name

College of Pharmaceutical Sciences

Zip code

Address

1-1-1 Noji-higashi, Kusatsu, Shiga 525-8577 JAPAN

TEL

077-561-5974

Homepage URL

Email

fujita-t@ph.ritsumei.ac.jp

Institute

Ritsumeikan University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co., Ltd., Towa Pharmaceutical co., ltd., JAPAN TOBACCO INC., Asahi Kasei Pharma Corporation., SHIONOGI & CO., LTD., ONO PHARMACEUTICAL CO., LTD., DAIICHI SANKYO RD NOVARE CO., LTD., DAIICHI SANKYO CO., LTD. Sawai Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd. , Japan Machinery Company

Name of secondary funder(s)

Same as above

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人相生会 博多クリニック（福岡県）

Date of disclosure of the study information

2018

Year

06

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

10

Month

11

Day

Date of IRB

Anticipated trial start date

2018

Year

06

Month

25

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

06

Month

19

Day

Last modified on

2018

Year

12

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037682