Clinical trials: Fed
Type 2 Diabetes Mellitus
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin IR tablet co-administered to…
- Trial name
- NCT00899470
- Testing
- Co-administration of Saxagliptin and Metformin IR, Fasted, Saxagliptin/Metformin, Fasting, Co-administration of Saxagliptin and Metformin IR, Fed
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Orthopoxviral Disease
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers.
- Trial name
- 246-Safety (NCT00907803)
- Testing
- ST-246 400 mg, ST-246 600 mg
- Where
- 3 sites in United States
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
Prostatic Hyperplasia
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin
It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the volunteers receive, in each period, the test formulation or the reference formulation, under…
- Trial name
- NCT01330303
- Testing
- Reference formulation, Test formulation
- Where
- Brazil
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Erectile Dysfunction
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.
- Trial name
- NCT01254396
- Testing
- Sildenafil
- Where
- Singapore
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bioequivalence
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions
This is a single center, Phase 1, randomized, open-label, single-dose, 2 treatment, 2-period,2-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin between the Test and Reference products in…
- Trial name
- NCT06987773
- Testing
- RLF-OD032 100 mg/mL oral suspension, Kuvan 100 MG Powder for Oral Solution
- Where
- Canada
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- APR Applied Pharma Research s.a.
Immunogenicity, Healthy Volunteers
Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Intas Pharmaceuticals Ltd.
- Trial name
- NCT04015232
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Healthy
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
- Trial name
- NCT01119443
- Testing
- PPX ER
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions
The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate 324 mg capsules, manufactured by the Mutual Pharmaceutical Company, to Quinine Sulphate 300 mg tablets, manufactured by the…
- Trial name
- NCT00727272
- Testing
- Quinine Sulfate Capsules 324 mg, Quinine Sulphate Tablets 300 mg
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)
The study will assess the bioequivalence between single doses of GXR manufactured in Merck Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug) under fed and fasted state in healthy…
- Trial name
- NCT03566810
- Testing
- Test GXR, Reference GXR
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Bioequivalence, Fixed Dose Combination Tablets
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects
This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions
- Conditions
- Bioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
- Trial name
- NCT02637037
- Testing
- dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao), dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions
The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation…
- Trial name
- NCT00830219
- Testing
- Ropinirole HCl 0.25 mg Tablets, Requip® 0.25 mg Tablets
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Lamotrigine 25 mg Chewable Tablets, Non-Fasting
The objective of this study is to compare the rate and extent of absorption of lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg chewable dispersible tablets under fed…
- Trial name
- NCT00838136
- Testing
- Lamotrigine 25 mg Chewable Tablets, Lamictal® 25 mg Chewable Tablets
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food
The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1810631 intended commercial formulation (iCF) under fed (Test treatment, T) and fasted (Reference treatment, R) conditions.
- Trial name
- NCT06075277
- Testing
- zongertinib
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.
- Trial name
- NCT02028767
- Testing
- Empagliflozin 2.5 mg, Empagliflozin 10 mg, Metformin 500 mg
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.
- Trial name
- NCT01099709
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Leishmaniasis
Safety, Tolerability and Pharmacokinetics (PKs) Investigation of GSK3186899 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability and PK profile of single and repeat ascending doses of GSK3186899 in healthy subjects.
- Trial name
- NCT03874234
- Testing
- GSK3186899
- Where
- United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Childhood Obesity, Infant Development
Unintentional Overfeeding of Formula Fed Infants
Although breast milk is recommended exclusively until 6 months of age, two-thirds of infants in the U.S. are fed infant formula.
- Trial name
- Whoa Baby (NCT02701868)
- Where
- United States
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Healthy
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers
The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC relative to Powder in Capsule (PIC) of…
- Trial name
- NCT01154218
- Testing
- crizotinib
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants
This study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and female participants.
- Trial name
- NCT03796260
- Testing
- Entrectinib Test Formulation (F1), Entrectinib Reference Formulation (F06)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy
Bioequivalence Study of Colchicine Tablets
This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with…
- Trial name
- NCT01021020
- Testing
- Colchicine, Colchicine/Probenecid
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.