Clinical trials: Bioequivalence Study in Healthy Subjects
Fever, Pain
Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions
This study aims to evaluate the bioequivalence of new formulated orodispersible tablet (ODT) containing 500 milligram (mg) paracetamol in comparison to the European marketed Alvedon (paracetamol) 500 mg film-coated tablets and…
- Trial name
- NCT06855576
- Testing
- Paracetamol ODT, Alvedon film-coated tablet, Panadol film-coated Tablet
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- HALEON
Pharmacokinetic Study
Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fasting Conditions
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each period.
- Trial name
- NCT01717235
- Testing
- Ropinirole hydrochloride CR Tablets 2mg
- Where
- India
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lupin Ltd.
Healthy
Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions
The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fed conditions…
- Trial name
- NCT01581788
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Hypertension
Bioequivalence Study in Healthy Subjects
This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial oral suspension of candesartan cilexetil (1…
- Trial name
- NCT00844324
- Testing
- Candesartan cilexetil
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans
Two formulations containing the same active pharmaceutical ingredient are considered bioequivalent if their relative bioavailability (rate and extent of drug absorption) falls within acceptable predetermined limits after…
- Trial name
- NCT07331194
- Testing
- HMPL-523 Acetate Tablets (Test Formulation), HMPL-523 Acetate Tablets (Reference Formulation)
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Fasting
Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fasting Condition
The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fasting condition.
- Trial name
- NCT01831661
- Testing
- Metformin Hydrochloride Extended-Release Tablets USP 750 mg, GLUCOPHAGE®XR
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Food Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fed…
- Trial name
- NCT00648856
- Testing
- Sertraline Hydrochloride Tablets 100 mg, Zoloft® Tablets 100 mg
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals 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.
Healthy
Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 mg Tablets
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of hydromorphone 8 mg to an equivalent oral dose of a commercially…
- Trial name
- NCT00853554
- Testing
- Hydromorphone Hydrochloride tablet 8 mg, Dilaudid® tablet 8 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy Male and Female Subjects
A Comparative Bioavailability Study of Reformulated Ibuprofen 2% and 4% Oral Suspensions (Berlin Chemie AG) and Versus Ibuprofen (Nurofen®) 200 mg/5 ml Oral Suspension
Purpose of the study is to compare three different formulations of Ibuprofen oral suspension (liquid taken by mouth) to see if there are any differences in how much of the active substance and how quickly it was taken up by by…
- Trial name
- NCT07036861
- Testing
- Ibuprofen 2%, Ibuprofen 4%
- Where
- 2 sites in Lithuania
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Muscular Atrophy, Spinal
Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants
The study is a randomized, single oral dose, crossover study in up to three parts to investigate the relative bioavailability and bioequivalence of two different formulations of risdiplam 5 mg (dispersible tablets) versus the…
- Trial name
- NCT04718181
- Testing
- risdiplam, omeprazole
- Where
- 4 sites in United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
Food Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's paroxetine hydrochloride controlled-release 25 mg tablets to GSK's Paxil CR™ 25 mg tablets following a single, oral 25 mg (1 x 25 mg) dose administered…
- Trial name
- NCT00647881
- Testing
- Paroxetine Hydrochloride Controlled-Release Tablets 25 mg, Paxil CR™ Tablets 25 mg
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Therapeutic Equivalency, Healthy
Bioequivalence Study of WP205 in Healthy Participants
This study is a single-center, randomized, open-label, two-period, two-sequence, single-dose, crossover bioequivalence trial conducted under fasting conditions in healthy adult volunteers.
- Trial name
- NCT07281872
- Testing
- Methylcobalamin Injection(WP205), Methylcobalamin for Injection
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Wanbangde Pharmaceutical Group Co., LTD
Healthy Subjects
PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers
A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults
- Trial name
- NCT07256600
- Testing
- DWJ1445, DWC202506
- Where
- South Korea
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy
A Study to Evaluate Oral Formulations of Tedizolid Phosphate in Healthy Participants (MK-1986-043)
The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time.
- Trial name
- NCT06733688
- Testing
- Tedizolid Phosphate Oral Formulation 1 (Reference), Tedizolid Phosphate Oral Formulation 2 (Test)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Participants
A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants
The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.
- Trial name
- NCT03627936
- Testing
- Lorcaserin manufactured at Zofingen, Lorcaserin manufactured at Kawashima
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Prostatic Hyperplasia
A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride…
- Trial name
- NCT00537654
- Testing
- Treatment sequence A, Treatment sequence B, Treatment sequence C
- Where
- 2 sites in United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Fasting
Bioequivalence Study of Sorafenib Tablet and Nexavar
Randomized, open-label, 3-way reference replicated crossover bioequivalence study of sorafenib 200 mg tablet and nexavar (reference) following a 200 mg dose in healthy subjects under fasting conditions.
- Trial name
- NCT02599337
- Testing
- Nexavar, Sorafenib
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Yabao Pharmaceutical Group
Epilepsy
Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China
It is an open-label, randomised, single dose, two-sequence cross-over study. Twenty-four eligible, healthy, Chinese male subjects will be enrolled after providing written informed consent.
- Trial name
- NCT01357902
- Testing
- Lamotrigine
- Where
- Hong Kong
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Fosinopril 40mg Tablets Under Fed Conditions
The objective of this study is to compare the relative bioavailability of fosinopril sodium 40 mg tablets (Ranbaxy Laboratories Limited, Lot No.
- Trial name
- NCT00776672
- Testing
- Fosinopril 40mg Tablets
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
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