Healthy Male Subjects Clinical Trial
Official title:
Comparison of Pulse Wave and Blood Pressure Parameters Before, During and After Exercise Ergometry in Healthy Male Subjects - a Randomized, Controlled, Single-blind Study
The objective of this randomized, controlled single blind study is to compare pulse wave and blood pressure measurements before, during and after exercise ergometry in healthy male subjects.
In a randomized single-blind study design the investigators explore how well blood pressure
parameters calculated using a Pulse Transit Time-based method (device: SOMNOtouchTM RESP)
match blood pressure parameters measured by a classic upper arm blood pressure cuff
(Mobil-O-Graph® PWA) under standardized load conditions (ergometry).
In 30 healthy male subjects (age 18 - 40 years), cardiovascular parameters before, during and
after a standardized load on a bicycle ergometer (half-lying position) are recorded with
three different devices (Mobil-O-Graph® PWA versus SOMNOtouchTM RESP versus GeTeMed Vitaguard
3100) and compared.
Primary outcome is the difference of the systolic blood pressure values between the devices
Mobil-O-Graph® PWA versus SOMNOtouchTM RESP during the three phases.
The Mobil-O-Graph® PWA blood pressure cuff is applied randomized to the arm with the
previously determined higher or lower systolic blood pressure mean difference. The subjects
are blinded to the results of the measurements during ergometry.
After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer
for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase
every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest period.
Measurements are taken every two minutes with the Mobil-O-Graph® PWA; data acquisition with
the SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 devices takes place continuously over a
total duration of 72 minutes.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05621447 -
A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects
|
Phase 1 | |
| Completed |
NCT02901366 -
Mass Balance Study of FYU-981
|
Phase 2 | |
| Not yet recruiting |
NCT01928563 -
Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine
|
Phase 1 | |
| Not yet recruiting |
NCT05559554 -
A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects
|
Phase 1 | |
| Completed |
NCT04512872 -
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT06111196 -
Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT03317652 -
Effect of Sodium Nitroprusside on Cerebral Blood Flow
|
N/A | |
| Completed |
NCT04655872 -
Mass Balance of Oral [14C]TPN171H in Healthy Male Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT02609711 -
Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects
|
Phase 1 | |
| Withdrawn |
NCT02560363 -
A Study to Compare the Pharmacokinetics of Different Formulations of AZD9977 and the Influence of Food in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT01261260 -
Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05072028 -
Mass Balance and Biotransformation Study of [14C]DBPR108 in Human
|
Phase 1 | |
| Completed |
NCT05446233 -
ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT05275010 -
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
|
Phase 1 | |
| Completed |
NCT04839744 -
A Comparative Study of TG103 Produced by Two Manufacturing Processes in Chinese Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT05792917 -
Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT03576651 -
A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT04825431 -
Mass Balance Study of [14C] TAS-205 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01819779 -
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)
|
Phase 1 | |
| Completed |
NCT05126784 -
AVT03 With Prolia in Healthy Male Subjects
|
Phase 1 |