Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Adult Male Volunteers

Outcome Measures

Primary Outcomes (3)

Cumulative excretion of 14C-labeled drug-related material (radioactivity in urine and fecal samples)
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in urine and feces.
up to 14 days
Identification of the Proportion of different metabolites to determine biotransformation pathway of Rongliflozin
Proportion of different metabolites(Rongliflozin and main metabolites).
up to 14 days
Distribution of radioactivity in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma
Radioactivity concentration in whole blood and plasma samples.
up to 11 days

Secondary Outcomes (2)

Quantitive analysis of the concentrations of Rongliflozinand main metabolites in plasma using the validated liquid chromatography-tandem mass spectrometry(LC-MS/MS) to obtain pharmacokinetic data
up to 11 days
Adverse events
up to 21 days

Study Arms (1)

[14C]- Rongliflozin

EXPERIMENTAL

Patients will receive single dose of \[14C\]- Rongliflozin (Suspension, 50mg/100μCi)

Drug: [14C]- Rongliflozin

Interventions

[14C]- RongliflozinDrug

Patients will receive single dose of orally \[14C\]- Rongliflozin on Day 1

[14C]- Rongliflozin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy males, 18 to 45 years at the time of screening.
Go to Weight\>50 kg, Body mass index (BMI) is 19\~26 kg/m2

Sponsors & Collaborators

Sunshine Lake Pharma Co., Ltd.
Industrylead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Study Officials

liyan Miao, MD
The First Affiliated Hospital of Soochow University
PRINCIPAL INVESTIGATOR

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 5, 2021

Study Start

December 9, 2021

Actual (reported)

Primary Completion

You may not qualify if:

Physical examination, routine laboratory tests, 12-lead ECG, Chest X-ray, abdominal B-ultrasound, New Coronavirus Testing and other is abnormal and clinically significant.
Positive testing for HIV, HBsAg, HBeAb, HCVAb or Syphilis antibody.
CYP3A4, uridine diphosphoglucuronyl transferase(UGT) inducers or inhibitors, and P-gp, breast cancer resistance protein(BCRP) Substrates were taken within 28 days before screening.
Use of any prescription or over-the-counter drug, any vitamin product, health care drug or Chinese herbal medicine within 14 days prior to screening.
Participants who have participated in any clinical trials within 3 months prior to screening and have used thetest drug or medical devices.
Participants who have been vaccinated within 1 month before screening or plan to be vaccinated during the trial period.
A history of any clinically serious illness or condition, including but not limited to circulatory, endocrine, nervous,digestive, urinary, or blood, immune, mental, and metabolic diseases, that the investigator considers to be likely to affect the results of the study.
People who have had heart disease such as heart failure, angina pectoris, myocardial infarction, and clinically significant arrhythmia.
A history of urinary tract infection or repeated hypoglycemia.
Participants who had undergone major surgery or whose surgical incision was not completely healed within 6 months before the screening period;Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, or an open biopsy or significant traumatic injury.
Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred withini 6 months before screening.
Significant clinical bleeding symptoms or definite bleeding tendency occurred within 3 months before screening.
Hemorrhoids or perianal diseases with regular/bleeding in the stool; Patients with gastrointestinal dysfunction, such as irritable bowel syndrome and inflammatory bowel disease, may be affected by drug absorption as determined by researchers.
Participants who have allergies or have special dietary requirements and cannot follow the standard diet.
Habitual constipation or diarrhea.
+9 more criteria

ADME Study of [14C]- Rongliflozin in Healthy Male Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (1)

[14C]- Rongliflozin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (1)

[14C]- Rongliflozin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations