Clinical trials: Healthy Female Volunteer
Female Contraception
Bioequivalence Study of Patches With Different Equilibration Profiles
The purpose of this single center, randomized, double-blind, 2 way crossover study was to determine the bioequivalence of a norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system.
- Trial name
- NCT00775086
- Testing
- norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system.
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy Volunteers
A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
- Trial name
- NCT07248865
- Testing
- CLYM116
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Climb Bio, Inc.
Healthy
Evaluation of A Novel Methodology in the Assessment of Urethral Function Using [S,S]-Reboxetine in Healthy Volunteers
[S,S]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in healthy volunteers using a novel methodology
- Trial name
- NCT00444548
- Testing
- [S,S]-Reboxetine
- Where
- Denmark
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1
This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in humans and will allow further development of G1T28 1 in patients with cancer to reduce chemotherapy-induced myelosuppression.
- Trial name
- NCT02243150
- Testing
- G1T28-1 (CDK 4/6 Inhibitor)
- Where
- Netherlands
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- G1 Therapeutics, Inc.
Healthy
AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian subjects
- Trial name
- JSAD/JMAD (NCT00785915)
- Testing
- AZD6765
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Pharmacodynamic Effects, Safety and Tolerability of Cilobradine, to Healthy Male and Female Volunteers, With an Intra-individual Comparison to Moxifloxacin in a Subset of Volunteers
Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT analysis of ECGs), and pharmacokinetic parameters
- Trial name
- NCT02264015
- Testing
- Cilobradine, low, film-coated tablets, Cilobradine, high, film-coated tablets, Moxifloxacin, film-coated tablets
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers
The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.
- Trial name
- SAD (NCT00803855)
- Testing
- AZD1446
- Where
- Sweden
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bladder Cancer
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers
This is an integrated Phase 1, single centre, 2-part, open-label, dose-escalation study conducted in healthy volunteers to assess the safety, tolerability, and PK of APL-1501 ER capsules in comparison to APL-1202 IR tablets.
- Trial name
- NCT06034015
- Testing
- APL-1202 and APL-1501 (Single ascending dose), APL-1202 and APL-1501 (Multiple Ascending dose)
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Ovulation Inhibition
Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens
The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.
- Trial name
- NCT00805415
- Testing
- EV/DNG (Qlaira, BAY86-5027, SH T00658K), EV/DNG (SH T00658L)
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Pharmacokinetics and Pharmacodynamics of Multiple 5 mg Doses of BI 1356 p.o. Given Once Daily Compared to Multiple 2.5 mg Doses Given Twice Daily in Healthy Male and Female Volunteers
The objective was to investigate the influence of 2 different dosage regimens (5 mg once daily vs. 2.5 mg twice daily) on the steady-state pharmacokinetics and pharmacodynamics of orally administered BI 1356.
- Trial name
- NCT02173652
- Testing
- BI 1356, high dose, BI 1356, low dose
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Impairment, Healthy Volunteers
A Study of TAK-279 in Adults With or Without Kidney Problems
The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with kidney problems compared to participants without kidney problems.
- Trial name
- NCT05992155
- Testing
- TAK-279
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Body Weight Changes
Efficacy Of Trimrox On Body Recomposition And Weight Management (TRCAP21)
Protocol Number: VNI/121/TrimRox: A unique stimulant- and sugar-free TRCAP21 Prodosomed® nutraceutical formulation, TrimROXTM, has been developed in a cGMP and NSF-certified manufacturing facility that is CFR-111 A compliant as…
- Trial name
- VNI (NCT05283525)
- Testing
- Anthropometric Measurement of the Chest, Upper Arm/Bicep, Hips, Thighs and Waist/ Belly in Inches, Oxygen Saturation, Total Blood Chemistry
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Victory Nutrition International, Inc.
Chronic Kidney Disease, Healthy Volunteers
A Study to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body, How it Moves Into, Through and Out of the Body When Single and Multiple Amounts Are Taken as Tablets in Japanese Healthy Male Participants
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). The kidneys filter extra water and waste out of the blood and make urine.
- Trial name
- NCT05800444
- Testing
- BAY3283142
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use
Food and Insulin Effect on QT/QTC Interval of ECG
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or…
- Conditions
- Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval, Moxifloxacin ECG Profile in Fed and Fasted State
- Trial name
- C11035 (NCT01642485)
- Testing
- Moxifloxacin 400 mg fasted, FDA breakfast, Continental breakfast
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Richmond Pharmacology Limited
Healthy
Study to Determine Tolerability of Single Increasing Dose of BIBN 4096 BS in Healthy Male and Female Volunteers
The objective of the present study was to obtain information about safety, tolerability and pharmacokinetics of BIBN 4096 BS after single subcutaneous administration of increasing doses in healthy male and female volunteers
- Trial name
- NCT02194348
- Testing
- BIBN 4096 BS - in single rising doses
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Safety, Tolerability and Pharmacokinetics of Increasing Doses of BIBN 4096 BS in Healthy Male and Female Volunteers
The objective of the present study was to obtain information about safety, tolerability and pharmacokinetics of BIBN 4096 BS after oral administration of increasing doses in healthy male and female volunteers.
- Trial name
- NCT02194335
- Testing
- BIBN 4096 BS - in single rising doses
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study of LY2140023 in Healthy Males and Females
The study will evaluate the effect of different particle size of LY2140023. The study involves 4 single doses of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth with a washout period of at least 3 days between doses.
- Trial name
- NCT01591330
- Testing
- LY2140023 Reference form, LY2140023 Test-Low, LY2140023 Test-Medium
- Where
- United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Denovo Biopharma LLC
Drug Interactions
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
The primary objective of this study is to evaluate the effect of multiple doses of a uridine diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl estradiol and levonorgestrel) on the PK of…
- Trial name
- NCT03324685
- Testing
- BIIB074, OC (ethinyl estradiol and levonorgestrel)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Volunteer
Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women
The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.
- Trial name
- NCT04418388
- Testing
- PBK-1801
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pharmbio Korea Co., Ltd.
Acute Kidney Injury (Nontraumatic)
Study of CXA-10 in Healthy Volunteers
This will be the first-in-human (FIH) study with CXA-10. The main purpose of this trial is to demonstrate the tolerability, safety and pharmacokinetics (PK) of CXA-10 at various incremental doses, and to demonstrate the safety…
- Trial name
- NCT02127190
- Testing
- CXA-10 emulsion
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Complexa, Inc.