Pure Global

A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects - Trial NCT03288740

Access comprehensive clinical trial information for NCT03288740 through Pure Global AI's free database. This Phase 1 trial is sponsored by Novo Nordisk A/S and is currently Completed. The study focuses on Diabetes,Diabetes Mellitus, Type 2. Target enrollment is 36 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT03288740
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT03288740
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
A Single-centre, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects

Study Focus

Semaglutide 0.5 mg

Interventional

drug

Sponsor & Location

Novo Nordisk A/S

Beijing, China

Timeline & Enrollment

Phase 1

Sep 21, 2017

Aug 07, 2018

36 participants

Primary Outcome

Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg),Area under the semaglutide plasma concentration time curve at steady state (semaglutide 1.0 mg)

Summary

The main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way
 the drug is distributed in the body over a period of time) following once-weekly
 administration of semaglutide in healthy Chinese subjects. Different dose levels (0.5 and 1.0
 mg) will be investigated in this trial. Participants will be administered semaglutide or
 placebo once-weekly by subcutaneous injection (under the skin fold of the abdominal wall)
 using a pen injector with a very small, thin needle by the trial doctor at the trial site for
 13 weeks. The trial consists of 23 visits in total, including visit for screening and safety
 tests, visit for dose administration and blood sample collection. The total time of
 participation will be approximately 18-22 weeks depending on participant's individual visit
 schedule.

ICD-10 Classifications

Type 2 diabetes mellitus
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT03288740

Non-Device Trial